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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® - 00888867379886

3.7MM DRILL BIT, CANNULATED, AO
ARTHREX, INC.
AR-8925DC
In Commercial Distribution

  • 00888867379886 ()
AR-8925DC

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867379824

Crclg Straight Passer, SM, Disposable
ARTHREX, INC.
AR-7825
In Commercial Distribution

  • 00888867379824 ()
AR-7825

  • Suturing unit, single-use

Arthrex® - 00888867379817

Crclg Passer, Right Offset, Disposable
ARTHREX, INC.
AR-7824R
In Commercial Distribution

  • 00888867379817 ()
AR-7824R

  • Suturing unit, single-use

Arthrex® - 00888867379800

Crclg Straight Passer, Troch, Disposable
ARTHREX, INC.
AR-7823
In Commercial Distribution

  • 00888867379800 ()
AR-7823

  • Suturing unit, single-use

Arthrex® - 00888867379794

Crclg Straight Passer, LRG, Disposable
ARTHREX, INC.
AR-7822
In Commercial Distribution

  • 00888867379794 ()
AR-7822

  • Suturing unit, single-use

Arthrex® - 00888867379787

Crclg Straight Passer, MD, Disposable
ARTHREX, INC.
AR-7821
In Commercial Distribution

  • 00888867379787 ()
AR-7821

  • Suturing unit, single-use

Arthrex® - 00888867379770

Mini CFS Instr Case, Split Style - Lid
ARTHREX, INC.
AR-18700CS-03
In Commercial Distribution

  • 00888867379770 ()
AR-18700CS-03

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379763

Mini CFS, Instr Case, Split - Instr Tray
ARTHREX, INC.
AR-18700CS-02
In Commercial Distribution

  • 00888867379763 ()
AR-18700CS-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379756

Mini CFS, Instr Case, Split - Caddy Tray
ARTHREX, INC.
AR-18700CS-01
In Commercial Distribution

  • 00888867379756 ()
AR-18700CS-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379725

Bio-Uni Instrument Caddy Lid
ARTHREX, INC.
AR-4081C-02
Not in Commercial Distribution

  • 00888867379725 ()
AR-4081C-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379718

Bio-Uni Instrument Caddy Base
ARTHREX, INC.
AR-4081C-01
Not in Commercial Distribution

  • 00888867379718 ()
AR-4081C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379701

Bio-Uni Instrument Case
ARTHREX, INC.
AR-4081C
Not in Commercial Distribution

  • 00888867379701 ()
AR-4081C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867378124

BioUni, BioPatella Disposables-Loaner
ARTHREX, INC.
RAR-4081S-DSP
Not in Commercial Distribution

  • 00888867378124 ()
RAR-4081S-DSP

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378117

Bio-Uni Instrument Set - Loaner
ARTHREX, INC.
RAR-4081S
Not in Commercial Distribution

  • 00888867378117 ()
RAR-4081S

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378100

Allograft OATS Disposables - Loaner
ARTHREX, INC.
RAR-4058S-DSP
Not in Commercial Distribution

  • 00888867378100 ()
RAR-4058S-DSP

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378094

AlloGraft OATS Instr Set-LOANER
ARTHREX, INC.
RAR-4058S
Not in Commercial Distribution

  • 00888867378094 ()
RAR-4058S

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378087

Allograft OATS & Bio-Uni Sets - Loaner
ARTHREX, INC.
RAR-4058MS
Not in Commercial Distribution

  • 00888867378087 ()
RAR-4058MS

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378070

Bio-Uni Instrument Set
ARTHREX, INC.
AR-4081S
Not in Commercial Distribution

  • 00888867378070 ()
AR-4081S

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378063

AlloGraft OATS Instr Set
ARTHREX, INC.
AR-4058S
Not in Commercial Distribution

  • 00888867378063 ()
AR-4058S

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378056

OATS & Bio-Uni Disposables - Loaner
ARTHREX, INC.
RAR-4058MS-D
Not in Commercial Distribution

  • 00888867378056 ()
RAR-4058MS-D

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378049

OATS & Bio-Uni Disposables
ARTHREX, INC.
AR-4058MS-D
Not in Commercial Distribution

  • 00888867378049 ()
AR-4058MS-D

  • Tendon/ligament graft preparation station

Arthrex® - 00888867378032

Allograft OATS & Bio-Uni Sets
ARTHREX, INC.
AR-4058MS
In Commercial Distribution

  • 00888867378032 ()
AR-4058MS

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867377882

DX Button, Stainless steel
ARTHREX, INC.
AR-8919-SS
In Commercial Distribution

  • 00888867377882 ()
AR-8919-SS

  • Orthopaedic fixation suture button

Arthrex® - 00888867377875

FiberLock Suspension System
ARTHREX, INC.
AR-8988-CP
In Commercial Distribution

  • 00888867377875 ()
AR-8988-CP

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867377806

Crclg Passing Hook LRG, Modular, Reuse
ARTHREX, INC.
AR-7837
In Commercial Distribution

  • 00888867377806 ()
AR-7837

  • Suturing unit, reusable

Arthrex® - 00888867377790

Crclg Passing Hook, MD, Modular, Reuse
ARTHREX, INC.
AR-7836
In Commercial Distribution

  • 00888867377790 ()
AR-7836

  • Suturing unit, reusable

Arthrex® - 00888867377783

Cerclage Curved Passing Hook, Reuse
ARTHREX, INC.
AR-7835
In Commercial Distribution

  • 00888867377783 ()
AR-7835

  • Suturing unit, reusable

Arthrex® - 00888867377776

Cerclage L Offset Passing Hook Reuse
ARTHREX, INC.
AR-7834L
In Commercial Distribution

  • 00888867377776 ()
AR-7834L

  • Suturing unit, reusable

Arthrex® - 00888867377769

Cerclage R Offset Passing Hook, Reuse
ARTHREX, INC.
AR-7834R
In Commercial Distribution

  • 00888867377769 ()
AR-7834R

  • Suturing unit, reusable

Arthrex® - 00888867377752

Crclg Trochanteric Passing Hook, Reuse
ARTHREX, INC.
AR-7833
In Commercial Distribution

  • 00888867377752 ()
AR-7833

  • Suturing unit, reusable

Arthrex® - 00888867377745

Crclg Straight Passing Hook LRG, Reuse
ARTHREX, INC.
AR-7832
In Commercial Distribution

  • 00888867377745 ()
AR-7832

  • Suturing unit, reusable

Arthrex® - 00888867377738

Crclg Straight Passing Hook MD, Reuse
ARTHREX, INC.
AR-7831
In Commercial Distribution

  • 00888867377738 ()
AR-7831

  • Suturing unit, reusable

Arthrex® - 00888867377400

ANKLE & FRACTURE SYS SCREW CADDY
ARTHREX, INC.
AR-8943C-SC1
In Commercial Distribution

  • 00888867377400 ()
AR-8943C-SC1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867377394

ANKLE & FRACTURE SYS PLATE CADDY
ARTHREX, INC.
AR-8943C-PC1
In Commercial Distribution

  • 00888867377394 ()
AR-8943C-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® - 00888867377370

DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
ARTHREX, INC.
AR-8990ST-2
In Commercial Distribution

  • 10888867377377 ()
  • 00888867377370 ()
AR-8990ST-2

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867377325

Mini Comprehensive Fix System, 1.0 mm
ARTHREX, INC.
AR-18700S-10
In Commercial Distribution

  • 00888867377325 ()
AR-18700S-10

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867377301

DX FiberTak Suture Anchor, #2 MTS w/ NDL
ARTHREX, INC.
AR-8991-1
In Commercial Distribution

  • 00888867377301 ()
AR-8991-1

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867377295

DX FiberTak Suture Anchor, #2 MTS w/ NDL
ARTHREX, INC.
AR-8991
In Commercial Distribution

  • 10888867377292 ()
  • 00888867377295 ()
AR-8991

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867377202

AVL ANGLED REAMER SLEEVE ASSEMBLY, 0
ARTHREX, INC.
AR-9297-00
In Commercial Distribution

  • 00888867377202 ()
AR-9297-00

  • Orthopaedic reamer guide

Arthrex® - 00888867377141

GLENOID INSERTER/IMPACTOR, X-LARGE
ARTHREX, INC.
AR-9241-04
In Commercial Distribution

  • 00888867377141 ()
AR-9241-04

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867377134

GLENOID INSERTER/IMPACTOR, LARGE
ARTHREX, INC.
AR-9241-03
In Commercial Distribution

  • 00888867377134 ()
AR-9241-03

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867377127

GLENOID INSERTER/IMPACTOR, MEDIUM
ARTHREX, INC.
AR-9241-02
In Commercial Distribution

  • 00888867377127 ()
AR-9241-02

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867377110

GLENOID INSERTER/IMPACTOR, SMALL
ARTHREX, INC.
AR-9241-01
In Commercial Distribution

  • 00888867377110 ()
AR-9241-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867377042

OSTEOAUGER BONE GRAFT HARVESTER, 6MM
ARTHREX, INC.
ABS-8000-06
In Commercial Distribution

  • 00888867377042 ()
ABS-8000-06

  • Orthopaedic osteotome

Arthrex® - 00888867377035

OSTEOAUGER BONE GRAFT HARVESTER, 8MM
ARTHREX, INC.
ABS-8000-08
In Commercial Distribution

  • 00888867377035 ()
ABS-8000-08

  • Orthopaedic osteotome

Arthrex® - 00888867377028

OSTEOAUGER BONE GRAFT HARVESTER, 10MM
ARTHREX, INC.
ABS-8000-10
In Commercial Distribution

  • 00888867377028 ()
ABS-8000-10

  • Orthopaedic osteotome

Arthrex® - 00888867375581

NANONEEDLE SCOPE, 250MM
ARTHREX, INC.
AR-3210-0045
In Commercial Distribution

  • 00888867375581 ()
AR-3210-0045

  • Endoscope video camera

Arthrex® - 00888867375574

NANONEEDLE SCOPE, 125MM
ARTHREX, INC.
AR-3210-0043
In Commercial Distribution

  • 00888867375574 ()
AR-3210-0043

  • Endoscope video camera

Arthrex® - 00888867375567

NANONEEDLE SCOPE, 180MM
ARTHREX, INC.
AR-3210-0044
In Commercial Distribution

  • 00888867375567 ()
AR-3210-0044

  • Rigid optical arthroscope, single-use
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