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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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Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07110
In Commercial Distribution

  • 00310866000343 ()
07110

  • Gingival retraction cord, non-medicated
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
591-009
In Commercial Distribution

  • 09348215137793 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
59-0109
In Commercial Distribution

  • 09348215137663 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
59-0009
In Commercial Distribution

  • 09348215137533 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-20-6909
In Commercial Distribution

  • 09348215073435 ()


  • Orthopaedic broach
No Description
W.H. Holden, Inc.
10-6105
In Commercial Distribution

  • D9281061050 ()


  • Dental suction system cannula, reusable
No Description
W.H. Holden, Inc.
10-6102
In Commercial Distribution

  • D9281061020 ()


  • Dental suction system cannula, reusable
No Description
Dynarex Corporation
4621
In Commercial Distribution

  • 00616784462134 ()
  • 00616784462110 ()


  • Tracheostomy tube neck holder, reusable
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0441
In Commercial Distribution

  • 00848665001877 ()


  • Surgical screwdriver, reusable
No Description
MedXpert GmbH
014-01009
In Commercial Distribution

  • 04260029580921 ()
014-01009

  • Rib/rib cage internal fixation/bracing system fixation grip/anchor
Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5947804
In Commercial Distribution

  • 04049098008013 ()
  • 04049098058223 ()


  • Electrocardiographic lead set, reusable
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-6401-9 G
In Commercial Distribution

  • 04049016124917 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-1601-9 G
In Commercial Distribution

  • 04049016124900 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
No Description
W.H. Holden, Inc.
10-5199-9SECH
In Commercial Distribution

  • D9281051999SECH0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5199-9HD
In Commercial Distribution

  • D9281051999HD0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5199-9CH
In Commercial Distribution

  • D9281051999CH0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5109NAPAV
In Commercial Distribution

  • D928105109NAPAV0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5109HF
In Commercial Distribution

  • D928105109HF0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5109HD
In Commercial Distribution

  • D928105109HD0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5109CH
In Commercial Distribution

  • D928105109CH0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5109B
In Commercial Distribution

  • D928105109B0 ()


  • Bone curette, reusable
The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.
OSTEOTEC LIMITED
OSTF-9
In Commercial Distribution

  • 05060183090101 ()
OSTF-9

  • Metacarpophalangeal/proximal interphalangeal joint prosthesis
No Description
SIZEWISE RENTALS, L.L.C.
PANACEA CONVERTIBLE PLUS 9 CELL MATTRESS
In Commercial Distribution

  • 00845699007981 ()


  • Alternating-pressure bed mattress
No Description
Bird & Cronin, LLC
08148228
In Commercial Distribution

  • 00610570157853 ()


  • Wearable percutaneous catheter/tube holder
No Description
Bird & Cronin, LLC
08148227
In Commercial Distribution

  • 00610570157846 ()


  • Wearable percutaneous catheter/tube holder
No Description
Bird & Cronin, LLC
BC 0345
In Commercial Distribution

  • 00610570107261 ()


  • Abdominal binder, single-use
Alkaline Wash Solution should be used in conjunction with reagents to clean cuvettes
RANDOX LABORATORIES LIMITED
RX8130
In Commercial Distribution

  • 05055273215007 ()
RX8130

  • Wash/cleaning solution IVD, automated/semi-automated system
No Description
HELENA LABORATORIES CORPORATION
552697
In Commercial Distribution

  • M5255526970 ()


  • Protein electrophoresis IVD, kit, electrophoresis
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