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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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Bookwalter Deaver retractor, 4 1/2" x 1 1/2" blade
AMBLER SURGICAL CORP.
70-616
In Commercial Distribution

  • 00190660131968 ()
70-616

  • Surgical self-retaining retractor, reusable
Braval® Nonwoven Sponges – 4 Ply 2 X 2 5000 PKG
PATTERSON DENTAL SUPPLY, INC.
070450940
In Commercial Distribution

  • D6620704509402 ()
  • D6620704509404 ()


  • Non-woven gauze pad, non-sterile
Rehab Shower Commode Chair Crossbrace, 14 1/2" & 17 1/2"
GF HEALTH PRODUCTS, INC.
9P835211J
In Commercial Distribution

  • M3689P835211J0 ()
  • M3689P835211J1 ()
9P835211J

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
Suture Anchor 6.5 PEEK Sterile Triple Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobraid, #2 White
DUNAMIS MEDICAL, LLC
DFX0032A
In Commercial Distribution

  • 10854629006205 ()
  • 00854629006208 ()
DFX0032A

  • Orthopaedic bone screw, non-bioabsorbable, sterile
CROSSBRACE 16W - ADJUSTABLE DEPTH & CBOLT-PR (INCLUDES 4 LINKAGES,2 SADDLE BUSHINGS, 2 CRADDLE AND HARDWARE, 2 GASKETS & HARDWARE)
GF HEALTH PRODUCTS, INC.
907632C1A
In Commercial Distribution

  • M368907632C1A1 ()
907632C1A

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution

  • 00607158000021 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0457
In Commercial Distribution

  • 09348215074371 ()


  • Orthopaedic implant aiming/guiding block, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0534
In Commercial Distribution

  • 09348215074326 ()


  • Orthopaedic implant aiming/guiding block, reusable
No Description
KEELER LIMITED
1205-P-1014
In Commercial Distribution

  • 05055272712545 ()


  • Indirect binocular ophthalmoscope, line-powered
No Description
Biomet Orthopedics, LLC
35-351564
In Commercial Distribution

  • 00880304359642 ()

  • .062 (D) X 9 (L) SNG/ST
35-351564

  • Orthopaedic bone wire
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