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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® - 00888867524873

Univers Revers Consolidated Glenoid Case
ARTHREX, INC.
AR-9615CGC
In Commercial Distribution

  • 00888867524873 ()
AR-9615CGC

  • Instrument tray, reusable

Arthrex® - 00888867519084

Rotator Cuff Repair Express Case
ARTHREX, INC.
AR-8405CRC
In Commercial Distribution

  • 00888867519084 ()
AR-8405CRC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867503069

Proximal Humeral Plate, Case Lid
ARTHREX, INC.
AR-9953C-01
In Commercial Distribution

  • 00888867503069 ()
AR-9953C-01

  • Instrument tray, reusable

Arthrex® - 00888867503052

Proximal Humeral Plate Instrument Case
ARTHREX, INC.
AR-9953C
In Commercial Distribution

  • 00888867503052 ()
AR-9953C

  • Instrument tray, reusable

Arthrex® - 00888867498389

Endoscopic Spine Case Pin Mat
ARTHREX, INC.
AR-S1000-C4-PM
In Commercial Distribution

  • 00888867498389 ()
AR-S1000-C4-PM

  • Sterilization container mat

Arthrex® - 00888867458048

Endoscopic Spine Trimano Arm Case
ARTHREX, INC.
AR-S1000-C4
In Commercial Distribution

  • 00888867458048 ()
AR-S1000-C4

  • Arthroscopic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867458635

Elbow Fracture System Case Lid
ARTHREX, INC.
AR-7650C-L
In Commercial Distribution

  • 00888867458635 ()
AR-7650C-L

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867458628

Elbow Fracture System Instrument Case
ARTHREX, INC.
AR-7650C-02
In Commercial Distribution

  • 00888867458628 ()
AR-7650C-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867458611

Elbow Fracture System Implant Case
ARTHREX, INC.
AR-7650C-01
In Commercial Distribution

  • 00888867458611 ()
AR-7650C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867445529

Troch. Nail System Case Lid
ARTHREX, INC.
AR-9095C-L
In Commercial Distribution

  • 00888867445529 ()
AR-9095C-L

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867428973

Hip Arthroscopy Instrument System, Case
ARTHREX, INC.
AR-6519C
In Commercial Distribution

  • 00888867428973 ()
AR-6519C

  • Device sterilization/disinfection container, reusable

Aurora Spine - B5211106010

ANTERIOR DISK PREP, INSTRUMENT CASE
AURORA SPINE, INC.
ADP
In Commercial Distribution

  • B5211106010 ()
110-601

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Aurora Spine - B5211106000

POSTERIOR DISK PREP, INSTRUMENT CASE
AURORA SPINE, INC.
PDP
In Commercial Distribution

  • B5211106000 ()
110-600

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Surgical Direct - B382SD98950

BL Type Retractor Sterilization Case
Surgical Direct, Inc.
SD9895
In Commercial Distribution

  • B382SD98950 ()
SD9895

  • Self-retaining surgical retractor, reusable

BOSS Instruments - 00888515329393

Bayonet Instrument Case, holds 16
BOSS INSTRUMENTS, LTD., INC.
72-2043
In Commercial Distribution

  • 00888515329393 ()
72-2043

  • Neurosurgical curette, reusable

GLOBAL ADVANTAGE - 10603295089551

GLOBAL ADVANTAGE HUMERAL CASE & INSERTS
DEPUY ORTHOPAEDICS, INC.
2128-61-040
Not in Commercial Distribution

  • 10603295089551 ()
212861040

  • Instrument tray, reusable

Arthrex® - 00888867013957

ACL PCL CORTICAL FIX. CASE
ARTHREX, INC.
AR-1359C
In Commercial Distribution

  • 00888867013957 ()
AR-1359C

  • Device sterilization/disinfection container, reusable

Panta® 2 - 10381780505754

Arthrodesis Nail System Screw Case
Ascension Orthopedics, Inc.
PAN-1010-0914
In Commercial Distribution

  • 10381780505754 ()
PAN-1010-0914

  • Device sterilization/disinfection container, reusable

MAYFIELD® - 10381780538011

Integra® BRS STERILIZATION CASE
INTEGRA LIFESCIENCES CORPORATION
417A1010
In Commercial Distribution

417A1010

  • Neurosurgical retraction system, brain

BOSS Instruments - 00888515008359

Microsurgical Instrument Sterilization Case 10x10x3"
BOSS INSTRUMENTS, LTD., INC.
00-1150
In Commercial Distribution

  • 00888515008359 ()
00-1150

  • Surgical instrument interim-placement holder, reusable

BOSS Instruments - 00888515008311

Microsurgical Instrument Sterilization Case 10x15x1.5"
BOSS INSTRUMENTS, LTD., INC.
00-1115
In Commercial Distribution

  • 00888515008311 ()
00-1115

  • Surgical instrument interim-placement holder, reusable

Arthrex® - 00888867022430

ACL REVISION SET INSTRUMENTATION CASE
ARTHREX, INC.
AR-1896RC
In Commercial Distribution

  • 00888867022430 ()
AR-1896RC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867021952

ACL TUNNEL PREPARATION INSTRUMENT CASE
ARTHREX, INC.
AR-1856C
In Commercial Distribution

  • 00888867021952 ()
AR-1856C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867021549

TRANSFIX II ACL, RECONSTRUCTION CASE
ARTHREX, INC.
AR-1817TC
In Commercial Distribution

  • 00888867021549 ()
AR-1817TC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867041196

GLENOID BONE LOSS INSTRUMENT CASE
ARTHREX, INC.
AR-7000C
In Commercial Distribution

  • 00888867041196 ()
AR-7000C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867039728

HIP ARTHROSCOPY MASTER INSTRUMENT CASE
ARTHREX, INC.
AR-6517C
In Commercial Distribution

  • 00888867039728 ()
AR-6517C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867038875

iBALANCE TKA, LMR INSTRUMENT CASE
ARTHREX, INC.
AR-605-C
In Commercial Distribution

  • 00888867038875 ()
AR-605-C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867028661

300 POWER SYSTEM INSTRUMENT CASE
ARTHREX, INC.
AR-300C
In Commercial Distribution

  • 00888867028661 ()
AR-300C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867028074

GRAFT PREP STATION INSTRUMENT CASE
ARTHREX, INC.
AR-2950C
In Commercial Distribution

  • 00888867028074 ()
AR-2950C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867027374

CLAVICLE PLATING SYSTEM INSTRUMENT CASE
ARTHREX, INC.
AR-2650C
In Commercial Distribution

  • 00888867027374 ()
AR-2650C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867026360

AC JOINT RECONSTRUCTION INSTRUMENT CASE
ARTHREX, INC.
AR-2255MC
In Commercial Distribution

  • 00888867026360 ()
AR-2255MC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867025493

OATS SIZER/TAMPS STERILIZATION CASE
ARTHREX, INC.
AR-1985C
In Commercial Distribution

  • 00888867025493 ()
AR-1985C

  • Device sterilization/disinfection container, reusable

WVSM Wireless Vital Signs Monitor - B3945100004030

Carry Case for 10 WVSMs
ATHENA GTX, INC.
Carry Case-10 WVSM
In Commercial Distribution

  • B3945100004030 ()
510-0004-03

  • Medical bag

WVSM Wireless Vital Signs Monitor - B3945100004020

Carry Case for 4 WVSMs
ATHENA GTX, INC.
Carry Case-4 WVSM
In Commercial Distribution

  • B3945100004020 ()
510-0004-02

  • Medical bag

WVSM Wireless Vital Signs Monitor - B3945100004010

Carry Case for 2 WVSMs
ATHENA GTX, INC.
Carry Case-2 WVSM
In Commercial Distribution

  • B3945100004010 ()
510-0004-01

  • Medical bag

BOSS Instruments - 00888515170414

Rhoton Case for 15 instruments
BOSS INSTRUMENTS, LTD., INC.
71-5120
In Commercial Distribution

  • 00888515170414 ()
71-5120

  • Surgical instrument interim-placement holder, reusable

Arthrex® - 00888867036789

600 POWER SYSTEM INSTRUMENT CASE
ARTHREX, INC.
AR-600C
In Commercial Distribution

  • 00888867036789 ()
AR-600C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035911

Collateral Ligament Recon. Inst. Case
ARTHREX, INC.
AR-5500C
In Commercial Distribution

  • 00888867035911 ()
AR-5500C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867048607

PARS ACHILLES REPAIR INSTRUMENT CASE
ARTHREX, INC.
AR-8860C
In Commercial Distribution

  • 00888867048607 ()
AR-8860C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867044517

GPS TARGETING DRILL GUIDE CASE
ARTHREX, INC.
AR-8655GC
In Commercial Distribution

  • 00888867044517 ()
AR-8655GC

  • Device sterilization/disinfection container, reusable
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