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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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LEE NO. 9 DISSECTOR, DOUBLE-ENDED, SHORT AND LONG 1.0 MM PADDLES
Grace Medical, Inc.
6.80.09
In Commercial Distribution

  • 00844505012225 ()


  • Open-surgery dissector
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen
Siemens Healthcare Diagnostics Inc.
10329874
In Commercial Distribution

  • 00630414549019 ()
  • 00630414009629 ()
A2162B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
W.H. Holden, Inc.
10-5188L
In Commercial Distribution

  • D928105188L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5187L
In Commercial Distribution

  • D928105187L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5186L
In Commercial Distribution

  • D928105186L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5185L
In Commercial Distribution

  • D928105185L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5184L
In Commercial Distribution

  • D928105184L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5183L
In Commercial Distribution

  • D928105183L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5182L
In Commercial Distribution

  • D928105182L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5181L
In Commercial Distribution

  • D928105181L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5180L
In Commercial Distribution

  • D928105180L0 ()


  • Bone curette, reusable
No Description
Lonza Verviers
BESP1685X2
In Commercial Distribution

  • 05407010125139 ()


  • Ex vivo cell culture medium
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000280 ()
PSP-091

  • Tendon graft
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
The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101011957 ()
TO-LBP-122

  • Orthopaedic fixation plate, non-bioabsorbable
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
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
Tinto Carbonic Anhydrase 9 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.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB64170 ()
BSB 6417

  • Carbonic anhydrase IVD, antibody
Tinto Carbonic Anhydrase 9 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.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB64160 ()
BSB 6416

  • Carbonic anhydrase IVD, antibody
Carbonic Anhydrase 9 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.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB64150 ()
BSB 6415

  • Carbonic anhydrase IVD, antibody
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
No Description
Drägerwerk AG & Co. KGaA
MP05820
In Commercial Distribution

  • 04048675665908 ()


  • Heat/moisture exchanger/microbial medical gas filter
No Description
Vista Dental
311009
In Commercial Distribution

  • 10818207022117 ()


  • Dental impression tray, single-use
No Description
Vista Dental
310009
In Commercial Distribution

  • 10818207022025 ()


  • Dental impression tray, single-use
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
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
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