Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Sterile disposable microkeratome blade, for use on the Amadeus® Microkeratome, Sample
MED LOGICS INC
ML7090 (+20)
In Commercial Distribution

  • 00850724001186 ()
  • 10850724001183 ()
ML7090 (+20)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® M2 Microkeratome, Sample
MED LOGICS INC
ML7050 (+20)
In Commercial Distribution

  • 00850724001063 ()
  • 10850724001060 ()
ML7050 (+20)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkeratome, Sample
MED LOGICS INC
ML7100 (-20)
In Commercial Distribution

  • 00850724001056 ()
  • 10850724001053 ()
ML7100 (-20)

  • Keratome blade, single-use
Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome
MED LOGICS INC
ML7040 (-20)
In Commercial Distribution

  • 10850724001046 ()
  • 00850724001049 ()
ML7040 (-20)

  • Keratome blade, single-use
The Vibrant Capsule is a small dimension, easy to swallow capsule, bearing pre-programed stimulations specifically designed for individuals with chronic constipation. Each box contains 2 blisters with capsules. Each blister contains 10 capsules.
VIBRANT LTD
1
In Commercial Distribution

  • 00860009189805 ()


  • Internal gastrointestinal vibratory-stimulation system capsule
20 Minute Biological Indicator, 25 Count
HU-FRIEDY MFG. CO., LLC
RR20BI
In Commercial Distribution

  • 10889950139889 ()


  • Biological sterilization indicator
20 Minute Reader Incubator
HU-FRIEDY MFG. CO., LLC
RR20READER
In Commercial Distribution

  • 10889950139872 ()


  • Test tube heater
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
E
In Commercial Distribution

  • 10810190015916 ()
904441st

  • Bone curette, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014704 ()
748221a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014698 ()
748211a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190018245 ()
904441t

  • Bone file/rasp, manual, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017927 ()
748221t

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017910 ()
748211

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017132 ()
391421t

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017125 ()
391411t

  • Clamp manipulation forceps
SUPERSONIC MACH 20
Supersonic Imagine, Inc.
SSIP95020-HOLX
In Commercial Distribution

  • 03760193600230 ()
SSIP95020-HOLX

  • General-purpose ultrasound imaging system
Synthetic Bone Substitute Granules
BIOMATLANTE
RT0701M+GS50
In Commercial Distribution

  • 03700501812870 ()

  • Total Volume: 0.5 Milliliter
RT0701M+GS50

  • Bone matrix implant, synthetic, non-antimicrobial
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1522
In Commercial Distribution

  • 13700773723253 ()
  • 03700773723256 ()


  • Lacrimal intubation set
Forceps
NOVASTEP
XFP03005
In Commercial Distribution

  • 03700879501048 ()
XFP03005

  • General internal orthopaedic fixation system implantation kit
Drill Guide
NOVASTEP
XDG01005
In Commercial Distribution

  • 03700879500850 ()
XDG01005

  • General internal orthopaedic fixation system implantation kit
IMPLANT 20:1
SIRONA Dental Systems GmbH
6043702
Not in Commercial Distribution

  • E27660437020 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
No Description
SEBIA
4786
In Commercial Distribution

  • 03607360047866 ()
4786

  • Protein electrophoresis IVD, control
No Description
SEBIA
4766
In Commercial Distribution

  • 03607360047668 ()
4766

  • Protein electrophoresis IVD, control
No Description
G21 SRL
900199
In Commercial Distribution

  • 08058964727596 ()


  • Balloon kyphoplasty kit
Cytokeratin 20 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB53910 ()
BSB 5391

  • Cytokeratin IVD, antibody
Cytokeratin 20 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB53900 ()
BSB 5390

  • Cytokeratin IVD, antibody
Cytokeratin 20 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB53890 ()
BSB 5389

  • Cytokeratin IVD, antibody
No Description
Keri Medical SA
211-A10020
In Commercial Distribution

  • 07640181161423 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Cytokeratin 20 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB67070 ()
BSB 6707

  • Cytokeratin IVD, antibody
Cytokeratin 20 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB67060 ()
BSB 6706

  • Cytokeratin IVD, antibody
Cytokeratin 20 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB67050 ()
BSB 6705

  • Cytokeratin IVD, antibody
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB5820
In Commercial Distribution

  • 00813909012919 ()

  • 8x9.4x25mm
NB5820

  • Bone matrix implant, synthetic, non-antimicrobial
Filters out particles and microbiological contamination 0.22 micron and larger.
HURRICANE MEDICAL INC
9301
In Commercial Distribution

  • 10813465012122 ()
  • 00813465012125 ()
9301

  • Syringe filter, clinical
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114247 ()

  • 16x10x32mm
TST20161032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114230 ()

  • 15x10x32mm
TST20151032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114162 ()

  • 18x10x32mm
TST20181032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113769 ()

  • 17x10x28mm
TST20171028

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113752 ()

  • 18x10x28mm
TST20181028

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113745 ()

  • 15x10x28mm
TST20151028

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113738 ()

  • 14x10x28mm
TST20141028

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113721 ()

  • 16x10x28mm
TST20161028

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113295 ()

  • 18x10x24mm
TST20181024

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113271 ()

  • 16x10x24mm
TST20161024

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113240 ()

  • 14x10x24mm
TST20141024

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844112786 ()

  • 16x10x20mm
TST20161020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844112762 ()

  • 14x10x20mm
TST20141020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844112748 ()

  • 12x10x20mm
TST20121020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844112731 ()

  • 11x10x20mm
TST20111020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844112311 ()

  • 12x10x24mm
TST20121024

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114254 ()

  • 17x10x32mm
TST20171032

  • Metallic spinal interbody fusion cage
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