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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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No Description
Bird & Cronin, LLC
08145712
In Commercial Distribution

  • 00610570019397 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145711
Not in Commercial Distribution

  • 00610570019380 ()


  • Wrist immobilizer, single-use
Extra-large
DARCO INTERNATIONAL, INC.
232-0010-60
In Commercial Distribution

  • 10609271051383 ()
  • 00609271051386 ()
  • 20609271051380 ()
232-0010-60

  • Lumbar spine orthosis
Large
DARCO INTERNATIONAL, INC.
232-0010-50
In Commercial Distribution

  • 20609271051373 ()
  • 00609271051379 ()
  • 10609271051376 ()
232-0010-50

  • Lumbar spine orthosis
Medium
DARCO INTERNATIONAL, INC.
232-0010-40
In Commercial Distribution

  • 20609271051359 ()
  • 00609271051355 ()
  • 10609271051352 ()
232-0010-40

  • Lumbar spine orthosis
Small
DARCO INTERNATIONAL, INC.
232-0010-30
In Commercial Distribution

  • 10609271051338 ()
  • 00609271051331 ()
  • 20609271051335 ()
232-0010-30

  • Lumbar spine orthosis
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-609
In Commercial Distribution

  • 09348215056209 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-34-1009
In Commercial Distribution

  • 09348215056070 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-16-0337
In Commercial Distribution

  • 09348215046361 ()


  • Surgical implant template, reusable
No Description
Lonza Verviers
BESP1685X2
In Commercial Distribution

  • 05407010125139 ()


  • Ex vivo cell culture medium
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0407-100
In Commercial Distribution

  • 00848665032338 ()


  • Surgical screwdriver, reusable
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000280 ()
PSP-091

  • Tendon graft
No Description
Spiggle & Theis Medizintechnik GmbH
40-510-01
In Commercial Distribution

  • 04250381888728 ()
40-510-01

  • General-purpose surgical spatula
No Description
Drägerwerk AG & Co. KGaA
MP05820
In Commercial Distribution

  • 04048675665908 ()


  • Heat/moisture exchanger/microbial medical gas filter
Cannulated instrument used to shape the bone cortex to place de cap of the WasherCap™ Fixation System correctly. The countersink is composed by two parts (the stop and the body). Both parts must be assembled to compose the countersink to ensure that it can be used in accordance with its intended use. The countersink need to be disassembled during its reprocessing in order to facilitate the cleaning process. Prior to the steriliation process, both parts should be assembled again in order to prepare the countersink for its next use.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739584 ()
  • 28437019739588 ()


  • Surgical countersink, reusable
Compatible with 2.7mm/3.5 mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 462
In Commercial Distribution

  • 00840118103114 ()

  • Height: 3.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Vista Dental
311009
In Commercial Distribution

  • 10818207022117 ()


  • Dental impression tray, single-use
Status DS™ ME/O/C/TH/P//BZ/BA/TC/A card; 10 Test kit
PRINCETON BIOMEDITECH CORPORATION
DOA-290-10-01
In Commercial Distribution

  • 10743816000471 ()
DOA-290-10-01

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
Status DS™ ME/O/C/TH/P//BZ/BA/TC/A card; 25 Test kit
PRINCETON BIOMEDITECH CORPORATION
DOA-290-25-01
In Commercial Distribution

  • 10743816000464 ()
DOA-290-25-01

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
No Description
Roche Diagnostics GmbH
11895427160
In Commercial Distribution

  • 00075537171097 ()
11895427160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
Roche Diagnostics GmbH
11895397160
In Commercial Distribution

  • 00075537007433 ()
11895397160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
9 Panel Drug Test Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
UCP BIOSCIENCES, INC.
U-CUP-794
In Commercial Distribution

  • 20817038022270 ()
  • 10817038022273 ()
  • 00817038022276 ()
U-CUP-794

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Vista Dental
310009
In Commercial Distribution

  • 10818207022025 ()


  • Dental impression tray, single-use
Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07910
In Commercial Distribution

  • 00310866000626 ()
07910

  • Gingival retraction cord, non-medicated
Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07710
In Commercial Distribution

  • 00310866000541 ()
07710

  • Gingival retraction cord, medicated
Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07610
In Commercial Distribution

  • 00310866000503 ()
07610

  • Gingival retraction cord, non-medicated
Content: 1 piece Height: 22 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD5501
In Commercial Distribution

  • D800ZRAD5501 ()


  • Dental bridge, ceramic
No Description
ZIRKONZAHN SRL
ZRAB1039
In Commercial Distribution

  • D800ZRAB1039 ()


  • Dental bridge, ceramic
Content: 2 pieces Height: 16 mm Translucent zirconia for single crowns to large bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB0501
In Commercial Distribution

  • D800ZRAB0501 ()


  • Dental bridge, ceramic
For the temporary, external anchoring of sutures and prevention of suture pull through.
PRESERVATION SOLUTIONS INC
SG-9
In Commercial Distribution

  • 00810805000231 ()


  • Suture retention device
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