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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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EDENTA - E312171216540081

Reamer with handle
EDENTA ETABLISSEMENT
171.21.654.008
In Commercial Distribution

  • E31217121654008101 ()
  • E312171216540081 ()


  • Manual endodontic file/rasp, reusable

LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mm - 00840117335035

With Graduated Markings
Dynarex Corporation
42305
In Commercial Distribution

  • 00810180841122 ()
  • 00840117335035 ()


  • Culture tube

In'tech Medical SAS - 03664888000346

K-WIRE WITH GRADUATION
IN'TECH MEDICAL
S06ITM365-C628
In Commercial Distribution

  • 03664888000346 ()


  • Hand-held surgical retractor, reusable

Arthrex® - 00888867241428

Multi-Driver with T-Handle
ARTHREX, INC.
AR-8964-23
In Commercial Distribution

  • 00888867241428 ()
AR-8964-23

  • Orthopaedic implant driver

Arthrex® - 00888867285156

COBB WITH SUCTION
ARTHREX, INC.
AR-9260-60
In Commercial Distribution

  • 00888867285156 ()
AR-9260-60

  • Drilling power tool attachment, basic

PROS Tail - 00816299012736

Wedge with Tail
Hovertech International
PROS-TAIL
In Commercial Distribution

  • 00816299012750 ()
  • 00816299012736 ()
  • 00816299012774 ()
PROS-TAIL

  • Freestanding patient positioner, single-use

Arthrex® - 00888867347731

ZebraProbe with Flushport
ARTHREX, INC.
AR-10500F
In Commercial Distribution

  • 00888867347731 ()
AR-10500F

  • Surgical drill guide, reusable

PASS LP - 03613720240846

SPEEDRIVER WITH T-HANDLE
MEDICREA INTERNATIONAL
A02230080
Not in Commercial Distribution

  • 03613720240846 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Diamond Orthopedic, LLC - B551DMD311430

Handle with quick-coupling
DIAMOND ORTHOPEDIC, LLC
DMD-311-430
In Commercial Distribution

  • B551DMD311430 ()
DMD-311-430

  • Surgical screwdriver, reusable

Dr. Brown's - 00072239321300

Gripebelt with teether
Dr. Brown's Company
HG104
In Commercial Distribution

  • 00072239321300 ()


  • Hot/cold therapy pack, reusable
  • Infant care kit
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