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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Low Profile Screw, 2.0 x 8mm, Cortical
ARTHREX, INC.
AR-18720-08
In Commercial Distribution

  • 00888867311671 ()
AR-18720-08

  • Orthopaedic bone screw (non-sliding)
Low Profile Screw, 2.0 x 7mm, Cortical
ARTHREX, INC.
AR-18720-07
In Commercial Distribution

  • 00888867311664 ()
AR-18720-07

  • Orthopaedic bone screw (non-sliding)
Low Profile Screw, 2.0 x 6mm, Cortical
ARTHREX, INC.
AR-18720-06
In Commercial Distribution

  • 00888867311657 ()
AR-18720-06

  • Orthopaedic bone screw (non-sliding)
PIN SET, MODULAR GLENOID SYSTEM
ARTHREX, INC.
AR-9607S
In Commercial Distribution

  • 00888867311442 ()
AR-9607S

  • Orthopaedic intraoperative positioning pin, single-use
Digital Repair System Instrument Case
ARTHREX, INC.
AR-4158HTC
In Commercial Distribution

  • 00888867311404 ()
AR-4158HTC

  • Device sterilization/disinfection container, reusable
DYNANITE PIP IMPLANT INSTRUMENT CASE
ARTHREX, INC.
AR-4158C
In Commercial Distribution

  • 00888867311398 ()
AR-4158C

  • Device sterilization/disinfection container, reusable
8mm x 3cm Passport Button Can w/Aux Lum
ARTHREX, INC.
AR-6592-08-30A
In Commercial Distribution

  • 00888867311367 ()
AR-6592-08-30A

  • Arthroscopic access cannula, single-use
Tube Set, Inflow, Arthroscopy
ARTHREX, INC.
AR-6413
In Commercial Distribution

  • 10888867311326 ()
  • 00888867311329 ()
AR-6413

  • Surgical irrigation tubing set, single-use
BioComposite 2.4mm Mini Hip PushLock
ARTHREX, INC.
AR-2924BCH-1
In Commercial Distribution

  • 00888867311312 ()
AR-2924BCH-1

  • Tendon/ligament bone anchor, bioabsorbable
BioComposite 2.4mm Mini Hip PushLock
ARTHREX, INC.
AR-2924BCH
In Commercial Distribution

  • 10888867311302 ()
  • 00888867311305 ()
AR-2924BCH

  • Tendon/ligament bone anchor, bioabsorbable
BC SWIVELOCK, 3.9X17.9MM
ARTHREX, INC.
AR-2326BCC
In Commercial Distribution

  • 10888867311289 ()
  • 00888867311282 ()
AR-2326BCC

  • Tendon/ligament bone anchor, bioabsorbable
DynaNite PIP - instrument only DS
ARTHREX, INC.
AR-4158DS
In Commercial Distribution

  • 00888867311190 ()
AR-4158DS

  • General internal orthopaedic fixation system implantation kit
MODULAR GLENOID SYSTEM IMPLANT SET
ARTHREX, INC.
AR-9615SI
Not in Commercial Distribution

  • 00888867310773 ()
AR-9615SI

  • Total reverse shoulder prosthesis
Reusable instr set for DynaNite PIP
ARTHREX, INC.
AR-4158S
In Commercial Distribution

  • 00888867310193 ()
AR-4158S

  • General internal orthopaedic fixation system implantation kit
12MM PHALANGEAL REAMER, CONVEX
ARTHREX, INC.
AR-4158PR-12V
In Commercial Distribution

  • 00888867310186 ()
AR-4158PR-12V

  • Bone-resection orthopaedic reamer, reusable
12MM PHALANGEAL REAMER, CONCAVE
ARTHREX, INC.
AR-4158PR-12C
In Commercial Distribution

  • 00888867310179 ()
AR-4158PR-12C

  • Bone-resection orthopaedic reamer, reusable
10MM PHALANGEAL REAMER, CONVEX
ARTHREX, INC.
AR-4158PR-10V
In Commercial Distribution

  • 00888867310162 ()
AR-4158PR-10V

  • Bone-resection orthopaedic reamer, reusable
10MM PHALANGEAL REAMER, CONCAVE
ARTHREX, INC.
AR-4158PR-10C
In Commercial Distribution

  • 00888867310155 ()
AR-4158PR-10C

  • Bone-resection orthopaedic reamer, reusable
8MM PHALANGEAL REAMER, CONVEX
ARTHREX, INC.
AR-4158PR-08V
In Commercial Distribution

  • 00888867310148 ()
AR-4158PR-08V

  • Bone-resection orthopaedic reamer, reusable
8MM PHALANGEAL REAMER, CONCAVE
ARTHREX, INC.
AR-4158PR-08C
In Commercial Distribution

  • 00888867310131 ()
AR-4158PR-08C

  • Bone-resection orthopaedic reamer, reusable
6MM PHALANGEAL REAMER, CONVEX
ARTHREX, INC.
AR-4158PR-06V
In Commercial Distribution

  • 00888867310124 ()
AR-4158PR-06V

  • Bone-resection orthopaedic reamer, reusable
6MM PHALANGEAL REAMER, CONCAVE
ARTHREX, INC.
AR-4158PR-06C
In Commercial Distribution

  • 00888867310117 ()
AR-4158PR-06C

  • Bone-resection orthopaedic reamer, reusable
DynaNite® Comp Plate. 2-Hole STR, 16mm
ARTHREX, INC.
AR-8771-0216S
In Commercial Distribution

  • 00888867339866 ()
AR-8771-0216S

  • Orthopaedic fixation plate, non-bioabsorbable
ApolloRF®SJ50, ASIPRATING ABLATOR 50°
ARTHREX, INC.
AR-9845
In Commercial Distribution

  • 00888867338708 ()
AR-9845

  • Endoscopic electrosurgical electrode, bipolar, single-use
IOBP HIP OPEN TIP PROCEDURE KIT
ARTHREX, INC.
ABS-2010-OT
In Commercial Distribution

  • 00888867338548 ()
ABS-2010-OT

  • Bone graft syringe, single-use
IOBP KNEE OPEN TIP PROCEDURE KIT
ARTHREX, INC.
ABS-2001-OT
In Commercial Distribution

  • 00888867338531 ()
ABS-2001-OT

  • Bone graft syringe, single-use
1.7mm TigerLink SutureTape, white/black
ARTHREX, INC.
AR-7538T-1
In Commercial Distribution

  • 00888867338524 ()
AR-7538T-1

  • Polyolefin/fluoropolymer suture, multifilament
1.7mm FiberLink SutureTape, white/blue
ARTHREX, INC.
AR-7538-1
In Commercial Distribution

  • 00888867338517 ()
AR-7538-1

  • Polyolefin/fluoropolymer suture, multifilament
1.7mm TigerLink SutureTape, white/black
ARTHREX, INC.
AR-7538T
In Commercial Distribution

  • 00888867338500 ()
  • 10888867338507 ()
AR-7538T

  • Polyolefin/fluoropolymer suture, multifilament
1.7mm FiberLink SutureTape, white/blue
ARTHREX, INC.
AR-7538
In Commercial Distribution

  • 00888867338494 ()
  • 10888867338491 ()
AR-7538

  • Polyolefin/fluoropolymer suture, multifilament
SCR, Knotless Implant System
ARTHREX, INC.
AR-2600SCR
In Commercial Distribution

  • 00888867338425 ()
AR-2600SCR

  • Tendon/ligament bone anchor, bioabsorbable
Mini CFS, 2.4 mm Module Caddy w/Lid
ARTHREX, INC.
AR-18700C-24
In Commercial Distribution

  • 00888867338401 ()
AR-18700C-24

  • Device sterilization/disinfection container, reusable
Mini CFS, 2.0 mm Module Caddy w/Lid
ARTHREX, INC.
AR-18700C-20
In Commercial Distribution

  • 00888867338395 ()
AR-18700C-20

  • Device sterilization/disinfection container, reusable
Mini CFS, 1.6 mm Module Caddy w/Lid
ARTHREX, INC.
AR-18700C-16
In Commercial Distribution

  • 00888867338388 ()
AR-18700C-16

  • Device sterilization/disinfection container, reusable
Mini CFS, 1.0/1.4 Module Caddy w/Lid
ARTHREX, INC.
AR-18700C-14
In Commercial Distribution

  • 00888867338371 ()
AR-18700C-14

  • Device sterilization/disinfection container, reusable
Mini CFS, Universal Module Lid
ARTHREX, INC.
AR-18700C-02
In Commercial Distribution

  • 00888867338357 ()
AR-18700C-02

  • Device sterilization/disinfection container, reusable
Mini CFS, Case Lid
ARTHREX, INC.
AR-18700C-01
In Commercial Distribution

  • 00888867338340 ()
AR-18700C-01

  • Device sterilization/disinfection container, reusable
BioTalus OATS Sizing Template
ARTHREX, INC.
ABS-4090T
In Commercial Distribution

  • 00888867338289 ()
ABS-4090T

  • Osteotomy guide, reusable
BioTalus OATS Disposable Kit
ARTHREX, INC.
ABS-4090D
In Commercial Distribution

  • 00888867338272 ()
ABS-4090D

  • Orthopaedic guidewire, single-use
BioTalus OATS Cutting Guide
ARTHREX, INC.
ABS-4090
In Commercial Distribution

  • 00888867338265 ()
ABS-4090

  • Osteotomy guide, reusable
SIZE 45 MODULAR GLENOID SYSTEM INSERT
ARTHREX, INC.
AR-9615C-3
In Commercial Distribution

  • 00888867338159 ()
AR-9615C-3

  • Device sterilization/disinfection container, reusable
PATELLA OATS THREADED PIN
ARTHREX, INC.
ABS-4085-TP
In Commercial Distribution

  • 00888867338050 ()
ABS-4085-TP

  • Custom-made orthopaedic/craniofacial surgical guide
LARGE PATELLA OATS PIN GUIDE
ARTHREX, INC.
ABS-4085-L
In Commercial Distribution

  • 00888867338043 ()
ABS-4085-L

  • Surgical drill guide, reusable
MEDIUM PATELLA OATS PIN GUIDE
ARTHREX, INC.
ABS-4085-M
In Commercial Distribution

  • 00888867338036 ()
ABS-4085-M

  • Surgical drill guide, reusable
SMALL PATELLA OATS PIN GUIDE
ARTHREX, INC.
ABS-4085-S
In Commercial Distribution

  • 00888867338029 ()
ABS-4085-S

  • Surgical drill guide, reusable
Ankle Fusion Instr. Case, 7.0 mm Tray
ARTHREX, INC.
AR-8970C-70
In Commercial Distribution

  • 00888867337435 ()
AR-8970C-70

  • Device sterilization/disinfection container, reusable
Ankle Fusion Instr. Case, 6.7 mm Tray
ARTHREX, INC.
AR-8970C-67
In Commercial Distribution

  • 00888867337428 ()
AR-8970C-67

  • Device sterilization/disinfection container, reusable
Ankle Fusion Caddy, 7.0 mm Insert
ARTHREX, INC.
AR-8970C-SC-70
In Commercial Distribution

  • 00888867337411 ()
AR-8970C-SC-70

  • Device sterilization/disinfection container, reusable
3.5x16mm Beveled FT Screw
ARTHREX, INC.
AR-8735BV-16
In Commercial Distribution

  • 00888867360617 ()
AR-8735BV-16

  • Orthopaedic bone screw (non-sliding)
3.5x14mm Beveled FT Screw, Strl
ARTHREX, INC.
AR-8735BV-14S
In Commercial Distribution

  • 00888867360600 ()
AR-8735BV-14S

  • Orthopaedic bone screw (non-sliding)
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