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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audioprint L-1 I MSI, 50g; clear transparent
pro3dure medical GmbH
50 g - Clear Transparent
In Commercial Distribution

  • EPRCA1040440 ()
A1040440

  • Earmould, custom-made
audioprint GR-11.1 I MSI 1 kg ; beige
pro3dure medical GmbH
1kg - beige
In Commercial Distribution

  • EPRCA1001520 ()
A1001520

  • Earmould, custom-made
Lateral Grid dS Breast 16CH I/T
Philips Medical Systems Nederland B.V.
989603209144
In Commercial Distribution

  • 00884838118720 ()


  • Needle guide, single-use
Pediatric Traction Boots, Orthographic I, II, Orthovision
STERIS CORPORATION
Table Pads
In Commercial Distribution

  • 00724995204938 ()
LS9982

  • Multifunction body cushion
Lateral Grid dS Breast 16CH I/T
Philips Ds North America LLC
98960320914
In Commercial Distribution

  • 00884838073173 ()


  • Needle guide, single-use
Medial Grid dS Breast 16CH I/T
Philips Ds North America LLC
98960320915
In Commercial Distribution

  • 00884838073166 ()


  • Needle guide, single-use
CR BM BIOPSY 11GX4 J,15G I
Cardinal Health 200, LLC
31-CR2ODF
In Commercial Distribution

  • 50195594716903 ()
  • 10195594716905 ()
31-CR2ODF

  • General surgical procedure kit, medicated
CR BM BIOPSY 11GX4 J,15G I
Cardinal Health 200, LLC
31-CR1CODF
In Commercial Distribution

  • 50195594716880 ()
  • 10195594716882 ()
31-CR1CODF

  • General surgical procedure kit, medicated
CR BM BIOPSY 11GX4 J,15G I
Cardinal Health 200, LLC
31-CR2CO
In Commercial Distribution

  • 50195594716828 ()
  • 10195594716820 ()
31-CR2CO

  • General surgical procedure kit, medicated
INSTRUMENT 7486282 I G FXD SCRWDRV L6.35
MEDTRONIC SOFAMOR DANEK, INC.
7486282
In Commercial Distribution

  • 00885074277615 ()


  • Surgical screwdriver, reusable
Medial Grid dS Breast 16CH I/T
Philips Medical Systems Nederland B.V.
989603209154
In Commercial Distribution

  • 00884838118737 ()


  • Needle guide, single-use
VERTAUX - Cross Link- I, Length 65mm, Titanium
Auxein Medical Private Limited
SP-323
In Commercial Distribution

  • 08903993311165 ()


  • Bone-screw internal spinal fixation system, non-sterile
VERTAUX - Cross Link- I, Length 55mm, Titanium
Auxein Medical Private Limited
SP-322
In Commercial Distribution

  • 08903993311158 ()


  • Bone-screw internal spinal fixation system, non-sterile
VERTAUX - Cross Link- I, Length 50mm, Titanium
Auxein Medical Private Limited
SP-321
In Commercial Distribution

  • 08903993311141 ()


  • Bone-screw internal spinal fixation system, non-sterile
Herpes Simplex Virus I & II Control Slides
BIO SB, INC.
BSB-9215-CS
In Commercial Distribution

  • B502BSB9215CS0 ()
BSB-9215-CS

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
CK MB CONTROL LEVEL I (1x 3mL)
DREW SCIENTIFIC, INC.
CKMC1-3
In Commercial Distribution

  • 00817274021279 ()


  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
ROBOTIC INTEGRATION INSTRUMENTS SYMPHONY MODULE I TRAY
Medos International Sàrl
2914-89-601
In Commercial Distribution

  • 10705034602714 ()
291489601

  • Instrument tray, reusable
Stem Extension Trial I/M Adapter (Large)
Ortho Development Corporation
665-0005-01
In Commercial Distribution

  • 00822409066308 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
Cones-Sleeves Stem Extension Trial I/M Adapter
Ortho Development Corporation
665-0006
In Commercial Distribution

  • 00822409066315 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
Lg Stem Ext Trial I/M Adapter
Ortho Development Corporation
665-0005
In Commercial Distribution

  • 00822409066292 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
Stem Extension Trial I/M Adapter (Medium)
Ortho Development Corporation
665-0003-01
In Commercial Distribution

  • 00822409066285 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
Stem Extension Trial I/M Adapter- (Small)
Ortho Development Corporation
665-0001-01
In Commercial Distribution

  • 00822409066261 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
SABER LUMBAR I/F CAGE SYSTEM RETRACTOR
DEPUY SPINE, LLC
287005000
Not in Commercial Distribution

  • 10705034215709 ()
287005000

  • Hand-held surgical retractor, reusable
Spiked E/M - I/M Tibial Extractor
Ortho Development Corporation
262-0154
In Commercial Distribution

  • 00822409050680 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
VITROS Chemistry Products %A1c Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801750
In Commercial Distribution

  • 10758750006960 ()
  • 20758750006967 ()
6801750

  • Glycated haemoglobin (HbA1c) IVD, control
VITROS Chemistry Products mALB Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801746
In Commercial Distribution

  • 10758750006946 ()
6801746

  • Microalbumin IVD, control
VITROS Chemistry Products Protein Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801744
In Commercial Distribution

  • 10758750006922 ()
6801744

  • Multiple clinical chemistry protein IVD, control
VITROS Chemistry Products hsCRP Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801742
In Commercial Distribution

  • 10758750006915 ()
6801742

  • C-reactive protein (CRP) IVD, calibrator
i see 2020 :Black :Black Mirrored :Donnerstag
IC! Berlin America LLC
00190064102779
In Commercial Distribution

  • 00190064102779 ()


  • Tinted non-prescription spectacles
Jonathan I. :Chrome :Marine Blue :Grey :Flex
IC! Berlin America LLC
00190064098317
In Commercial Distribution

  • 00190064098317 ()


  • Tinted non-prescription spectacles
MEDIVEN ANGIO 15-20 PETITE BLACK SIZE I
MEDI MANUFACTURING, INC.
3X47511
In Commercial Distribution

  • 04061736671274 ()


  • Compression/pressure sock/stocking, single-use
MEDIVEN ANGIO 20-30 PET CARAMEL SIZE I
MEDI MANUFACTURING, INC.
3Y47111
In Commercial Distribution

  • 04061736671137 ()


  • Compression/pressure sock/stocking, single-use
XA AneuScore I, 2x (5x100µl), Aneusomy Probe
MetaSystems Probes GmbH
D-5604-500-TC
In Commercial Distribution

  • 04251315817296 ()
D-5604-500-TC

  • Assay development analyte-specific reagent IVD
XA AneuScore I, 2x 100µl, Aneusomy Probe
MetaSystems Probes GmbH
D-5604-100-TC
In Commercial Distribution

  • 04251315817289 ()
D-5604-100-TC

  • Assay development analyte-specific reagent IVD
20° Posterior shade I, mould 30M, U
The Myerson Company Limited
T540IU030M
In Commercial Distribution

  • 00842326168312 ()


  • Resin artificial teeth
20° Posterior shade I, mould 28M, U
The Myerson Company Limited
T540IU028M
In Commercial Distribution

  • 00842326168299 ()


  • Resin artificial teeth
0° Posterior shade I, mould 33L, L
The Myerson Company Limited
T520IL033L
In Commercial Distribution

  • 00842326163805 ()


  • Resin artificial teeth
0° Posterior shade I, mould 33M, L
The Myerson Company Limited
T520IL033M
In Commercial Distribution

  • 00842326163799 ()


  • Resin artificial teeth
0° Posterior shade I, mould 31L, L
The Myerson Company Limited
T520IL031L
In Commercial Distribution

  • 00842326163782 ()


  • Resin artificial teeth
0° Posterior shade I, mould 31M, L
The Myerson Company Limited
T520IL031M
In Commercial Distribution

  • 00842326163775 ()


  • Resin artificial teeth
0° Posterior shade I, mould 29L, L
The Myerson Company Limited
T520IL029L
In Commercial Distribution

  • 00842326163768 ()


  • Resin artificial teeth
0° Posterior shade I, mould 29M, L
The Myerson Company Limited
T520IL029M
In Commercial Distribution

  • 00842326163751 ()


  • Resin artificial teeth
0° Posterior shade I, mould 33L, U
The Myerson Company Limited
T520IU033L
In Commercial Distribution

  • 00842326163744 ()


  • Resin artificial teeth
0° Posterior shade I, mould 33M, U
The Myerson Company Limited
T520IU033M
In Commercial Distribution

  • 00842326163737 ()


  • Resin artificial teeth
0° Posterior shade I, mould 31L, U
The Myerson Company Limited
T520IU031L
In Commercial Distribution

  • 00842326163720 ()


  • Resin artificial teeth
0° Posterior shade I, mould 31M, U
The Myerson Company Limited
T520IU031M
In Commercial Distribution

  • 00842326163713 ()


  • Resin artificial teeth
0° Posterior shade I, mould 29L, U
The Myerson Company Limited
T520IU029L
In Commercial Distribution

  • 00842326163706 ()


  • Resin artificial teeth
0° Posterior shade I, mould 29M, U
The Myerson Company Limited
T520IU029M
In Commercial Distribution

  • 00842326163690 ()


  • Resin artificial teeth
Conometric Abutment Ø3.8/3.0/15°/Ø4.5/I
Dentsply Implants Manufacturing GmbH
32264106
Not in Commercial Distribution

  • EFRI322641062 ()
26-4106

  • Dental implant suprastructure, permanent, preformed
Conometric Abutment Ø3.8/2.0/15°/Ø4.5/I
Dentsply Implants Manufacturing GmbH
32264105
Not in Commercial Distribution

  • EFRI322641052 ()
26-4105

  • Dental implant suprastructure, permanent, preformed
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