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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PC1003 Foot Section with cutout 20" x 20" x 1/2"
POLYMER CONCEPTS, INC.
PC1003
In Commercial Distribution

  • 00810048240203 ()


  • Operating table patient pressure distribution pad, reusable
Phasix Mesh, 8" x 8" (20 cm x 20 cm), Square
Davol Inc.
1192020
In Commercial Distribution

  • 00801741107603 ()

  • Length: 20 Centimeter
  • Width: 20 Centimeter
1192020

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GRADIA® Cartridge(1CORE Cartridge 10 mL (20 g), 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003652
In Commercial Distribution

  • 14548161282970 ()
003652

  • Dental composite resin
GRADIA® Cartridge(1CORE Cartridge 10 mL (20 g), 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003652
In Commercial Distribution

  • D0470036521 ()
003652

  • Dental composite resin
No Description
Biomet Orthopedics, LLC
110027855
In Commercial Distribution

  • 00880304806382 ()

  • 20 MM 20 MM
110027855

  • Orthopaedic bone staple, non-adjustable
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10258-2020G
In Commercial Distribution

  • 09421904065413 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10256-2020G
In Commercial Distribution

  • 09421904065345 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10254-2020G
In Commercial Distribution

  • 09421904065277 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10248-2020P
In Commercial Distribution

  • 09421904065208 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, biologic-polymer composite
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10246-2020P
In Commercial Distribution

  • 09421904065130 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, biologic-polymer composite
The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10244-2020P
In Commercial Distribution

  • 09421904065062 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, biologic-polymer composite
OSSIOfiber® Compression Staple, 20x20 mm. Package contains: 1 Implant.
OSSIO LTD
OF1062020S
In Commercial Distribution

  • 07290017630892 ()

  • 20 x 20 mm
OF1062020S

  • Orthopaedic bone staple, non-adjustable
OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrument pack.
OSSIO LTD
OF2062020S
In Commercial Distribution

  • 07290017630700 ()

  • 20 x 20 mm
OF2062020S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Orthopaedic bone staple, non-adjustable
Case of 20 boxes of Insulin Syringes attached needle 0.3ml/cc 29G x 5/16"
HEPRO.US INC.
CT - 0.3ml/cc 29G x 5/16"
In Commercial Distribution

  • 00850578007457 ()
  • 85057800745702 ()


  • Insulin syringe/needle, basic
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 30 CC, 2-WAY
Cardinal Health 200, LLC
23020ICC
In Commercial Distribution

  • 20192253066279 ()
  • 10192253066272 ()
  • 50192253066270 ()
23020ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20520ICC
In Commercial Distribution

  • 20192253066248 ()
  • 10192253066241 ()
  • 50192253066249 ()
20520ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 30 CC, 2-WAY
Cardinal Health 200, LLC
23020ICC
Not in Commercial Distribution

  • 20192253030560 ()
  • 10192253030563 ()
  • 50192253030561 ()
23020ICC

  • Indwelling urethral drainage balloon catheter, antimicrobial
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20520ICC
Not in Commercial Distribution

  • 20192253030492 ()
  • 10192253030495 ()
  • 50192253030493 ()
20520ICC

  • Indwelling urethral drainage balloon catheter, antimicrobial
No Description
Biomet Orthopedics, LLC
909102
In Commercial Distribution

  • 00880304411227 ()
909102

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Micro 20 Gauge Tips 500pk
ULTRADENT PRODUCTS, INC.
1437
In Commercial Distribution

  • 00883205022400 ()
1437

  • Syringe tip cap
Micro 20 Gauge Tips 100pk
ULTRADENT PRODUCTS, INC.
1252
In Commercial Distribution

  • 00883205022080 ()
1252

  • Syringe tip cap
Micro 20 Gauge Tips 20pk
ULTRADENT PRODUCTS, INC.
1168
In Commercial Distribution

  • 00883205022028 ()
1168

  • Dental suction system cannula, single-use
A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
STANBIO LABORATORY, L.P.
1430-050
In Commercial Distribution

  • 00657498001356 ()
  • 00657498001363 ()
1430-050

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1920
In Commercial Distribution

  • 00857377006124 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
CODAN Luer-Lock 20 ml, single use, syringe, sterile
Codan Medical ApS
62.7704
In Commercial Distribution

  • 05706225001123 ()
  • 05706225001147 ()


  • General-purpose syringe, single-use
No Description
W.H. Holden, Inc.
10-7320
In Commercial Distribution

  • D9281073200 ()


  • Instrument tray, reusable
No Description
BLINK DEVICE COMPANY
TVCAB05
In Commercial Distribution

  • 00850023319173 ()
TVCAB05

  • Block-monitoring peripheral nerve electrical stimulation system
Module
NOVASTEP
ACC1001P0010
Not in Commercial Distribution

  • 03700879505879 ()
ACC1001P0010

  • Device sterilization/disinfection container, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190016838 ()
232004t

  • Suturing unit, reusable
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10507786
In Commercial Distribution

  • 04056869001289 ()


  • PET/CT system
Gold based noble metal
ARGEN CORPORATION, THE
120223
In Commercial Distribution

  • D818120223 ()
120223

  • Dental casting noble alloy
Leica Biosystems Accessory
Leica Biosystems Nussloch GmbH
000000014047836709
In Commercial Distribution

  • 04049188052711 ()

  • Device Size Text, specify:
14047836709

  • Microscope slide coverslip IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-2010-20
Not in Commercial Distribution

  • 04049016072423 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-2005-20
Not in Commercial Distribution

  • 04049016040279 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1010-20
Not in Commercial Distribution

  • 04049016040262 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1005-20
Not in Commercial Distribution

  • 04049016040255 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1003-20
Not in Commercial Distribution

  • 04049016040248 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 920
In Commercial Distribution

  • 00840118103596 ()

  • Height: 3.2 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10818674022269 ()
743221t

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

  • 10818674022252 ()
743211

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
214142
In Commercial Distribution

  • 10818674021286 ()
904441m

  • Bone curette, reusable
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
214143
In Commercial Distribution

  • 10818674021132 ()
391421m

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
214144
In Commercial Distribution

  • 10818674021125 ()
391411m

  • Clamp manipulation forceps
Absorbent Paper Points, 02 Taper 20, 200 Points, P 21
Meta Biomed Co., Ltd.
2846
In Commercial Distribution

  • 08806387828464 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 20, 200 Points, P 31R
Meta Biomed Co., Ltd.
2719
In Commercial Distribution

  • 08806387827191 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 20, 200 Points, P 31S
Meta Biomed Co., Ltd.
2607
In Commercial Distribution

  • 08806387826071 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 20, 200 Points, P 61
Meta Biomed Co., Ltd.
2497
In Commercial Distribution

  • 08806387824978 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 20, 120 Points, P 71
Meta Biomed Co., Ltd.
2378
In Commercial Distribution

  • 08806387823780 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 20, 200 Points, P 71
Meta Biomed Co., Ltd.
2235
In Commercial Distribution

  • 08806387822356 ()


  • Endodontic paper point
No Description
Joline GmbH & Co. KG
US9503
In Commercial Distribution

  • 04250203940894 ()


  • General-purpose syringe, single-use
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