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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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Histo-Tek® - 00615233082831

Standard with Lid Detached Blue
SAKURA FINETEK U.S.A., INC.
9340
In Commercial Distribution

  • 00615233082831 ()
9340

  • Histology tissue cassette IVD, laboratory processing, single-use

MaxFuse® PEEK VBR SYSTEM - 00846468057558

MAXFUSE INSERTER SHAFT WITH STOP
Pioneer Surgical Technology, Inc.
62-INSRTSHAFT-S
Not in Commercial Distribution

  • 00846468057558 ()


  • General internal orthopaedic fixation system implantation kit

Calix Spinal Implant System - M697X00300161

In-line Inserter Assembly, with Stop
Xtant Medical Holdings, Inc.
X003-0016
In Commercial Distribution

  • M697X00300160 ()
  • M697X00300161 ()


  • Polymeric spinal interbody fusion cage

Blizzard Casualty Blanket XL + Heat pads - M689BH01020

Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689BH01020 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use

Blizzard Casualty Blanket XL + Heat pads - M689BH01010

Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689BH01010 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use

Brickyard Stand-Alone ALIF - 00843210184166

U-Joint Awl with Sleeve, 15mm
Altus Spine, LLC
1030-2615A
In Commercial Distribution

  • 00843210184166 ()


  • Bone awl, reusable

AnyPlus® - 08809695609480

Guidewire Driver With Strike Plate
GS Medical Co., Ltd.
US114-9023
In Commercial Distribution

  • 08809695609480 ()
US114-9023

  • Surgical screwdriver, reusable

Draffin bipod suspension for mouth gags - 04250676733917

paediatric size, with Magauran plate
Spiggle & Theis Medizintechnik GmbH
40-335-01
In Commercial Distribution

  • 04250676733917 ()
40-335-01

  • Surgical instrument assist arm system, manually-adjusted

Draffin bipod suspension for mouth gags - 04250676734044

adult size, with Magauran plate
Spiggle & Theis Medizintechnik GmbH
40-335-00
In Commercial Distribution

  • 04250676734044 ()
40-335-00

  • Surgical instrument assist arm system, manually-adjusted

CARDINAL HEALTH - 10888439081282

TOTAL JOINT WITH BASIN PK
Cardinal Health 200, LLC
SOP69TJECF
In Commercial Distribution

  • 50888439081280 ()
  • 10888439081282 ()
SOP69TJECF

  • Orthopaedic surgical procedure kit, non-medicated, single-use
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