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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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Arthrex® - 00888867400634

1.9/2.4 Double ended drill guide
ARTHREX, INC.
AR-9938-01
In Commercial Distribution

  • 00888867400634 ()
AR-9938-01

  • Surgical drill guide, reusable

Arthrex® - 00888867400603

Snap-off Compression FT Pin System
ARTHREX, INC.
AR-9938S
In Commercial Distribution

  • 00888867400603 ()
AR-9938S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867400597

Snap-off Compression FT Pin Sys Case Lid
ARTHREX, INC.
AR-9938C-01
In Commercial Distribution

  • 00888867400597 ()
AR-9938C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867400580

Snap-off Compression FT Pin System Case
ARTHREX, INC.
AR-9938C
In Commercial Distribution

  • 00888867400580 ()
AR-9938C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867400573

Cannulated Scalpel Handle 2.4
ARTHREX, INC.
AR-8770-11
In Commercial Distribution

  • 00888867400573 ()
AR-8770-11

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867400566

Cannulated Scalpel Handle 1.6
ARTHREX, INC.
AR-8750-15
In Commercial Distribution

  • 00888867400566 ()
AR-8750-15

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867400559

Cannulated Scalpel Handle 1.6 MIS
ARTHREX, INC.
AR-8741KH
In Commercial Distribution

  • 00888867400559 ()
AR-8741KH

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867400542

Cannulated Scalpel Handle 1.35
ARTHREX, INC.
AR-9938-12
In Commercial Distribution

  • 00888867400542 ()
AR-9938-12

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867400436

VAULTLOCK/KEEL UPGRADE INSTRUMENT CASE
ARTHREX, INC.
AR-9217VKC
In Commercial Distribution

  • 00888867400436 ()
AR-9217VKC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867399372

Univers Revers CA Head & 155 Trials Case
ARTHREX, INC.
AR-9501H-CA155C
In Commercial Distribution

  • 00888867399372 ()
AR-9501H-CA155C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867392052

2.4MM VOLAR DIST RAD PLT SYS TRAY INSERT
ARTHREX, INC.
AR-8924C-03
In Commercial Distribution

  • 00888867392052 ()
AR-8924C-03

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867387850

ANKLE & FRACTURE SYS SCREW CADDY LID, TI
ARTHREX, INC.
AR-9943C-SC1L
In Commercial Distribution

  • 00888867387850 ()
AR-9943C-SC1L

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867381858

ANKLE & FRACTURE SYS PLATE CADDY, TI
ARTHREX, INC.
AR-9943C-PC1
In Commercial Distribution

  • 00888867381858 ()
AR-9943C-PC1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867377387

ANKLE & FRACTURE SYS INSTR CASE
ARTHREX, INC.
AR-8943C-1
In Commercial Distribution

  • 00888867377387 ()
AR-8943C-1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370036

2.4MM 3H AND 5H VOLAR PLT CADDY
ARTHREX, INC.
AR-8916C-30
In Commercial Distribution

  • 00888867370036 ()
AR-8916C-30

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370029

2.4MM VOLAR DIST RAD PLT SYS CADDY, LID
ARTHREX, INC.
AR-8924C-02
In Commercial Distribution

  • 00888867370029 ()
AR-8924C-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370012

2.4MM VOLAR DIST RAD PLT SYS CADDY
ARTHREX, INC.
AR-8924C-01
In Commercial Distribution

  • 00888867370012 ()
AR-8924C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370005

2.4MM VOLAR DIST RAD PLT SYS CASE
ARTHREX, INC.
AR-8924C
In Commercial Distribution

  • 00888867370005 ()
AR-8924C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867368293

TI PL DISTAL FIBULA / HOOK PLATE CADDY
ARTHREX, INC.
AR-9943C-PC-01
In Commercial Distribution

  • 00888867368293 ()
AR-9943C-PC-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867368279

ANKLE & FRACTURE SYS INSTR CASE, TI
ARTHREX, INC.
AR-9943C-1
In Commercial Distribution

  • 00888867368279 ()
AR-9943C-1

  • Device sterilization/disinfection container, reusable

Reprocessed Suture Passer, Transosseous - B390AR10001

No Description
SURETEK MEDICAL
AR-1000
In Commercial Distribution

  • B390AR10001 ()


  • Suturing unit, reprocessed

Arthrex® - 00888867364356

Percutaneous Insertion Handle, 4.5mm
ARTHREX, INC.
AR-8963-24
In Commercial Distribution

  • 00888867364356 ()
AR-8963-24

  • Surgical implant/trial-implant/sizer holder, reusable

Arthrex® - 00888867364257

Primary Pilon Fusion Screw Caddy, Lid
ARTHREX, INC.
AR-8963C-SC-01
In Commercial Distribution

  • 00888867364257 ()
AR-8963C-SC-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867364233

Primary Pilon Fusion Case, Lid
ARTHREX, INC.
AR-8963C-04
In Commercial Distribution

  • 00888867364233 ()
AR-8963C-04

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867353251

Univers Revers Apex Instrument Case
ARTHREX, INC.
AR-9501RAC
In Commercial Distribution

  • 00888867353251 ()
AR-9501RAC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867352759

Kreulock Comp.Screw Sysm Case
ARTHREX, INC.
AR-8787CLC
In Commercial Distribution

  • 00888867352759 ()
AR-8787CLC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867351776

UNIVERS REVERS™ MGS, HA DRILL, CADDY
ARTHREX, INC.
AR-9579C-DCHA
In Commercial Distribution

  • 00888867351776 ()
AR-9579C-DCHA

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867351769

UNIVERS REVERS™ MGS, FA 20° DRILL, CADDY
ARTHREX, INC.
AR-9579C-DC20FA
In Commercial Distribution

  • 00888867351769 ()
AR-9579C-DC20FA

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867351752

UNIVERS REVERS™ MGS, FA 10° DRILL, CADDY
ARTHREX, INC.
AR-9579C-DC10FA
In Commercial Distribution

  • 00888867351752 ()
AR-9579C-DC10FA

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867351271

UNIVERS REVERS™ MGS, AUG BASEPLATE CASE
ARTHREX, INC.
AR-9579C
In Commercial Distribution

  • 00888867351271 ()
AR-9579C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867347731

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

  • 00888867347731 ()
AR-10500F

  • Surgical drill guide, reusable

Arthrex® - 00888867347663

Univers Revers Humeral Broach Inst. Case
ARTHREX, INC.
AR-9501HBC
In Commercial Distribution

  • 00888867347663 ()
AR-9501HBC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403239

3.5MM LOCK COMPRESSION PLT, OUTER CASE
ARTHREX, INC.
AR-7657C
In Commercial Distribution

  • 00888867403239 ()
AR-7657C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403222

DIST FIBULA PLT SS / 3.5MM LCP SS, CADDY
ARTHREX, INC.
AR-8943C-PC-02
In Commercial Distribution

  • 00888867403222 ()
AR-8943C-PC-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403215

3.5MM LOCK COMPR PLT SS, TRAY INSERT
ARTHREX, INC.
AR-8657C-01
In Commercial Distribution

  • 00888867403215 ()
AR-8657C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403208

3.5MM LOCK COMPR PLT TI, TRAY INSERT
ARTHREX, INC.
AR-7657C-01
In Commercial Distribution

  • 00888867403208 ()
AR-7657C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867402225

FiberTak Button drill guide
ARTHREX, INC.
AR-3683
In Commercial Distribution

  • 00888867402225 ()
AR-3683

  • Surgical drill guide, reusable

Arthrex® - 00888867390409

AUGMENTED VAULTLOCK XL INSTRUMENT CASE
ARTHREX, INC.
AR-9217AVC-XL
In Commercial Distribution

  • 00888867390409 ()
AR-9217AVC-XL

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867390393

AUGMENTED VAULTLOCK INSTRUMENT CASE
ARTHREX, INC.
AR-9217AVC
In Commercial Distribution

  • 00888867390393 ()
AR-9217AVC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867381469

Mini CFS, Instr Case Split Style
ARTHREX, INC.
AR-18700CS
In Commercial Distribution

  • 00888867381469 ()
AR-18700CS

  • Device sterilization/disinfection container, reusable
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