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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® - 00888867227958

LASSO, LG CURVE, STRAIGHT
ARTHREX, INC.
SP-5068-LGS
In Commercial Distribution

  • 00888867227958 ()
SP-5068-LGS

  • Suturing unit, reusable

Arthrex® - 00888867226982

UNI CA HUMERAL HEADS X-RAY TEMPLATES
ARTHREX, INC.
AR-706
In Commercial Distribution

  • 00888867226982 ()
AR-706

  • Surgical implant template, reusable

Arthrex® - 00888867226128

iBalance, Patella Drill Guide Combo
ARTHREX, INC.
AR-602-49
In Commercial Distribution

  • 00888867226128 ()
AR-602-49

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

Arthrex® - 00888867226074

DISTAL TIBIA ALLOGRAFT WORKSTATION CASE
ARTHREX, INC.
AR-7001C
In Commercial Distribution

  • 00888867226074 ()
AR-7001C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867226067

2.8MM CANNULATED DRILL GUIDE, X-LARGE
ARTHREX, INC.
AR-9215-8CG
In Commercial Distribution

  • 00888867226067 ()
AR-9215-8CG

  • Surgical drill guide, reusable

Arthrex® - 00888867225855

Low Profile Screw Case Tray Insert 3
ARTHREX, INC.
AR-8946HC
In Commercial Distribution

  • 00888867225855 ()
AR-8946HC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867225077

Instrument Case, Rev CA Head & Adptr Trl
ARTHREX, INC.
AR-9501HC-RCAC
In Commercial Distribution

  • 00888867225077 ()
AR-9501HC-RCAC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867224049

Arthroscopic IB Guidewire
ARTHREX, INC.
SP-1678K
In Commercial Distribution

  • 00888867224049 ()
SP-1678K

  • Wire/ligature passer, single-use

Arthrex® - 00888867223998

Arthroscopic IB Guidewire Sleeve
ARTHREX, INC.
SP-1678C-02
In Commercial Distribution

  • 00888867223998 ()
SP-1678C-02

  • Surgical drill guide, reusable

Arthrex® - 00888867223974

FIBERWIRE CART
ARTHREX, INC.
AR-7200CART
In Commercial Distribution

  • 00888867223974 ()
AR-7200CART

  • Electromechanical device/system transport trolley

Arthrex® - 00888867223967

4K SynergyUHD4 Trimano Camera Holder
ARTHREX, INC.
AR-3210-0011
In Commercial Distribution

  • 00888867223967 ()
AR-3210-0011

  • Surgical camera holder

Arthrex® - 00888867221383

Drill Guide for 3.5mm Screws, Special
ARTHREX, INC.
SP-4162G
In Commercial Distribution

  • 00888867221383 ()
SP-4162G

  • Surgical drill guide, reusable

Arthrex® - 00888867221222

Boney Bankart Lasso, Right
ARTHREX, INC.
SP-5068-40BBR
In Commercial Distribution

  • 00888867221222 ()
SP-5068-40BBR

  • Suturing unit, reusable

Arthrex® - 00888867221215

Boney Bankart Lasso, Left
ARTHREX, INC.
SP-5068-40BBL
In Commercial Distribution

  • 00888867221215 ()
SP-5068-40BBL

  • Suturing unit, reusable

Arthrex® - 00888867220027

T15 HEXALOBE DRIVESHAFT, SOLID, STRAIGHT
ARTHREX, INC.
AR-8950SD-15
In Commercial Distribution

  • 00888867220027 ()
AR-8950SD-15

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867219977

WRIST PLTG SYS DISTRACTOR CADDY BASE&LID
ARTHREX, INC.
AR-8916C-25
In Commercial Distribution

  • 00888867219977 ()
AR-8916C-25

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867218222

BIO-UNI INSTRUMENT CASE
ARTHREX, INC.
AR-4080C
In Commercial Distribution

  • 00888867218222 ()
AR-4080C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867217478

BioSync Wedge Instrumentation Set
ARTHREX, INC.
AR-8948S
In Commercial Distribution

  • 00888867217478 ()
AR-8948S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867217461

BioSync Reconstruction Instrument Case
ARTHREX, INC.
AR-8948C
In Commercial Distribution

  • 00888867217461 ()
AR-8948C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867217348

WRIST PLTG SYS 9H PLT CADDY BASE&LID
ARTHREX, INC.
AR-8916C-22
In Commercial Distribution

  • 00888867217348 ()
AR-8916C-22

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867216471

GRAFTPRO GRAFT PREP INSTRUMENT CASE
ARTHREX, INC.
AR-2950DC
In Commercial Distribution

  • 00888867216471 ()
AR-2950DC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867213074

WRIST PLTG SYS 3.5MM SCRW CADDY BASE&LID
ARTHREX, INC.
AR-8916C-24
In Commercial Distribution

  • 00888867213074 ()
AR-8916C-24

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867213067

WRIST PLTG SYS 2.4MM SCRW CADDY BASE&LID
ARTHREX, INC.
AR-8916C-23
In Commercial Distribution

  • 00888867213067 ()
AR-8916C-23

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867212329

INSTRUMENT CASE, MASTER HAND
ARTHREX, INC.
AR-2200C
In Commercial Distribution

  • 00888867212329 ()
AR-2200C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867212244

OSTEOTOMY INSTRUMENT CASE
ARTHREX, INC.
AR-13330C
In Commercial Distribution

  • 00888867212244 ()
AR-13330C

  • Device sterilization/disinfection container, reusable

PROTECTOR - 00888118061584

No Description
KLS-Martin L.P.
38-111-02-02
Not in Commercial Distribution

  • 00888118061584 ()


  • Finger protector, reusable

PACKER - 00888118061157

GRAFT, TERRY, ANGLED
KLS-Martin L.P.
38-013-16-07
In Commercial Distribution

  • 00888118061157 ()

  • 13 CM


  • Orthopaedic implant impactor, reusable

PACKER - 00888118061140

GRAFT, TERRY, STRAIGHT
KLS-Martin L.P.
38-012-16-07
In Commercial Distribution

  • 00888118061140 ()

  • 11 CM


  • Orthopaedic implant impactor, reusable

FORCEPS - 00888118054791

FLAP MARKER, DASSUMPCAO
KLS-Martin L.P.
28-300-15-07
In Commercial Distribution

  • 00888118054791 ()

  • 15.5 CM


  • Soft-tissue surgical hook, reusable

ELEVATOR - 00888118109132

PLACING, PERIOSTEAL, MEMBRANE, KORNER WESTERMANN
KLS-Martin L.P.
23-500-02-07
In Commercial Distribution

  • 00888118109132 ()

  • 18 CM


  • Periosteal elevator, reusable

Cannulated Driver Handle - 00812926021331

No Description
Trilliant Surgical, LLC
210-00-003
In Commercial Distribution

  • 00812926021331 ()


  • Surgical instrument handle, non-torque-limiting

3S Hemi Handle - 00812926020129

No Description
Trilliant Surgical, LLC
111-00-002
In Commercial Distribution

  • 00812926020129 ()


  • Surgical instrument handle, non-torque-limiting

1.5MM SYSTEM - 00888233005609

No Description
BIOMET MICROFIXATION, INC
01-7189
In Commercial Distribution

  • 00888233005609 ()
01-7189

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

OTOBRADER - 00888118146472

DINGMAN, LEFT
KLS-Martin L.P.
37-683-02-07
In Commercial Distribution

  • 00888118146472 ()

  • 15 CM


  • ENT elevator

OTOBRADER - 00888118146465

DINGMAN, RIGHT
KLS-Martin L.P.
37-683-01-07
In Commercial Distribution

  • 00888118146465 ()

  • 15 CM


  • ENT elevator

4WEB Medical - 00812998054763

No Description
4web Medical
ASTS-000310
In Commercial Distribution

  • 00812998054763 ()
ASTS-000310

  • Bone file/rasp, manual, reusable

4WEB Medical - 00812998054732

No Description
4web Medical
ASTS-000308
In Commercial Distribution

  • 00812998054732 ()
ASTS-000308

  • Bone file/rasp, manual, reusable

4WEB Medical - 00812998054718

No Description
4web Medical
ASTS-000302
In Commercial Distribution

  • 00812998054718 ()
ASTS-000302

  • Bone file/rasp, manual, reusable

4WEB Medical - 00812998054428

No Description
4web Medical
ATS-020000-01
In Commercial Distribution

  • 00812998054428 ()
ATS-020000-01

  • General internal orthopaedic fixation system implantation kit

4WEB Medical - 00812998054084

No Description
4web Medical
4WEB-LAS-000018
In Commercial Distribution

  • 00812998054084 ()
4WEB-LAS-000018

  • Orthopaedic implantation hammering attachment
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