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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® - 00888867236448

Saw Depth Guide X-Large-17
ARTHREX, INC.
AR-4085X-17
In Commercial Distribution

  • 00888867236448 ()
AR-4085X-17

  • Surgical depth gauge, reusable

Arthrex® - 00888867236431

Saw Depth Guide Large-20
ARTHREX, INC.
AR-4085L-20
In Commercial Distribution

  • 00888867236431 ()
AR-4085L-20

  • Surgical depth gauge, reusable

Arthrex® - 00888867236400

Saw Depth Guide Medium-20
ARTHREX, INC.
AR-4085M-20
In Commercial Distribution

  • 00888867236400 ()
AR-4085M-20

  • Surgical depth gauge, reusable

American Medicals - B35618736200

No Description
American Medicals
1
In Commercial Distribution

  • B35618736200 ()


  • Surgical screwdriver, reusable

Arthrex® - 00888867236394

Saw Depth Guide Medium-17
ARTHREX, INC.
AR-4085M-17
In Commercial Distribution

  • 00888867236394 ()
AR-4085M-17

  • Surgical depth gauge, reusable

Arthrex® - 00888867236370

Saw Depth Guide Small-17
ARTHREX, INC.
AR-4085S-17
In Commercial Distribution

  • 00888867236370 ()
AR-4085S-17

  • Surgical depth gauge, reusable

Arthrex® - 00888867236226

Oblong Cutter Large-20
ARTHREX, INC.
AR-4083L-20
In Commercial Distribution

  • 00888867236226 ()
AR-4083L-20

  • Orthopaedic osteotome

Arthrex® - 00888867236219

Oblong Cuter Large-17
ARTHREX, INC.
AR-4083L-17
In Commercial Distribution

  • 00888867236219 ()
AR-4083L-17

  • Orthopaedic osteotome

Arthrex® - 00888867236202

Oblong Cutter Large-14
ARTHREX, INC.
AR-4083L-14
In Commercial Distribution

  • 00888867236202 ()
AR-4083L-14

  • Orthopaedic osteotome

Arthrex® - 00888867236196

Oblong Cutter Medium-20
ARTHREX, INC.
AR-4083M-20
In Commercial Distribution

  • 00888867236196 ()
AR-4083M-20

  • Orthopaedic osteotome

Arthrex® - 00888867236189

Oblong Cutter Medium-17
ARTHREX, INC.
AR-4083M-17
In Commercial Distribution

  • 00888867236189 ()
AR-4083M-17

  • Orthopaedic osteotome

Arthrex® - 00888867236172

Oblong Cutter Medium-14
ARTHREX, INC.
AR-4083M-14
In Commercial Distribution

  • 00888867236172 ()
AR-4083M-14

  • Orthopaedic osteotome

Arthrex® - 00888867236165

Oblong Cutter Small-17
ARTHREX, INC.
AR-4083S-17
In Commercial Distribution

  • 00888867236165 ()
AR-4083S-17

  • Orthopaedic osteotome

Arthrex® - 00888867236158

Oblong Cutter Small-14
ARTHREX, INC.
AR-4083S-14
In Commercial Distribution

  • 00888867236158 ()
AR-4083S-14

  • Orthopaedic osteotome

Arthrex® - 00888867236141

Sizer/Drill Pin Guide X-Large-20
ARTHREX, INC.
AR-4080X-20
In Commercial Distribution

  • 00888867236141 ()
AR-4080X-20

  • Surgical drill guide, reusable

Arthrex® - 00888867236134

Sizer/Drill Pin Guide X-Large-17
ARTHREX, INC.
AR-4080X-17
In Commercial Distribution

  • 00888867236134 ()
AR-4080X-17

  • Surgical drill guide, reusable

Arthrex® - 00888867236127

Sizer/Drill Pin Guide Large-20
ARTHREX, INC.
AR-4080L-20
In Commercial Distribution

  • 00888867236127 ()
AR-4080L-20

  • Surgical drill guide, reusable

Arthrex® - 00888867236103

Sizer/Drill Pin Guide Large-14
ARTHREX, INC.
AR-4080L-14
In Commercial Distribution

  • 00888867236103 ()
AR-4080L-14

  • Surgical drill guide, reusable

Arthrex® - 00888867236080

Sizer/Drill Pin Guide Medium-17
ARTHREX, INC.
AR-4080M-17
In Commercial Distribution

  • 00888867236080 ()
AR-4080M-17

  • Surgical drill guide, reusable

Arthrex® - 00888867236073

Sizer/Drill Pin Guide Medium-14
ARTHREX, INC.
AR-4080M-14
In Commercial Distribution

  • 00888867236073 ()
AR-4080M-14

  • Surgical drill guide, reusable

Arthrex® - 00888867236066

Sizer/Drill Pin Guide Small-17
ARTHREX, INC.
AR-4080S-17
In Commercial Distribution

  • 00888867236066 ()
AR-4080S-17

  • Surgical drill guide, reusable

Arthrex® - 00888867236059

Sizer/Drill Pin Guide Small-14
ARTHREX, INC.
AR-4080S-14
In Commercial Distribution

  • 00888867236059 ()
AR-4080S-14

  • Surgical drill guide, reusable

Arthrex® - 00888867235786

iBalance Patella Protector, Extra Large
ARTHREX, INC.
AR-623-44
In Commercial Distribution

  • 00888867235786 ()
AR-623-44

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

Arthrex® - 00888867235762

iBalance Patella Protector, Medium
ARTHREX, INC.
AR-623-42
In Commercial Distribution

  • 00888867235762 ()
AR-623-42

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

Arthrex® - 00888867235748

iBalance Patella Protector, Extra Small
ARTHREX, INC.
AR-623-40
In Commercial Distribution

  • 00888867235748 ()
AR-623-40

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

Arthrex® - 00888867233751

PARALLEL DRILL GUIDE, PATELLA FRACTURE
ARTHREX, INC.
AR-5050-11
In Commercial Distribution

  • 00888867233751 ()
AR-5050-11

  • Surgical drill guide, reusable

Arthrex® - 00888867198333

ANKLE FUSION CADDY POLYPRO REPLACEMENT
ARTHREX, INC.
AR-8970C-SC-01
Not in Commercial Distribution

  • 00888867198333 ()
AR-8970C-SC-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867196759

3.5MM, RATCHET DRILL SLEEVE
ARTHREX, INC.
AR-1510FD-35
In Commercial Distribution

  • 00888867196759 ()
AR-1510FD-35

  • Surgical drill guide, reusable

Arthrex® - 00888867196742

3.0MM, RATCHET DRILL SLEEVE
ARTHREX, INC.
AR-1510FD-30
In Commercial Distribution

  • 00888867196742 ()
AR-1510FD-30

  • Surgical drill guide, reusable

Arthrex® - 00888867196698

Synergy Scope System Case
ARTHREX, INC.
AR-3102C
In Commercial Distribution

  • 00888867196698 ()
AR-3102C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867196377

MEGABITER, STRAIGHT TIP, LEFT CUT, 5.5MM
ARTHREX, INC.
AR-41006L
In Commercial Distribution

  • 00888867196377 ()
AR-41006L

  • General-purpose surgical scissors, reusable

Arthrex® - 00888867196360

MEGABITER, STRAIGHT TIP, RIGHT CUT, 5.5M
ARTHREX, INC.
AR-41006R
In Commercial Distribution

  • 00888867196360 ()
AR-41006R

  • General-purpose surgical scissors, reusable

Arthrex® - 00888867196339

MegaBiter, Straight Tip, 5.5MM X 2.5MM
ARTHREX, INC.
AR-41006
In Commercial Distribution

  • 00888867196339 ()
AR-41006

  • General-purpose surgical scissors, reusable

Arthrex® - 00888867195486

Joint Space Guide
ARTHREX, INC.
AR-10200
In Commercial Distribution

  • 00888867195486 ()
AR-10200

  • Surgical drill guide, reusable

Arthrex® - 00888867195318

INST. CASE, NAUTILUS REAMER
ARTHREX, INC.
AR-9216NRC
In Commercial Distribution

  • 00888867195318 ()
AR-9216NRC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867195028

ANKLE FUSION PLATING INSTRUMENT CASE
ARTHREX, INC.
AR-8970C
In Commercial Distribution

  • 00888867195028 ()
AR-8970C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867184800

LAPIDUS SYSTEM ADDITIONAL PLATE CADDY
ARTHREX, INC.
AR-8941LS-APC
In Commercial Distribution

  • 00888867184800 ()
AR-8941LS-APC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867184411

2.9MM X 305MM CROCHET HOOK
ARTHREX, INC.
SP-5046NH
In Commercial Distribution

  • 00888867184411 ()
SP-5046NH

  • Bone hook

Arthrex® - 00888867184404

3.5MM X 305MM CROCHET HOOK
ARTHREX, INC.
SP-5006NH
In Commercial Distribution

  • 00888867184404 ()
SP-5006NH

  • Bone hook

Arthrex® - 00888867184367

SCORPION SUTURE PASSER, CLOSED JAW
ARTHREX, INC.
SP-13990-2
In Commercial Distribution

  • 00888867184367 ()
SP-13990-2

  • Suturing unit, reusable

Arthrex® - 00888867184299

2.75MM Meniscus REPR NDL GRSPR W/SR
ARTHREX, INC.
AR-11750SR
In Commercial Distribution

  • 00888867184299 ()
AR-11750SR

  • Suturing unit, reusable

Arthrex® - 00888867184176

CANNULA BENDING TOOL,8G/4.3MM+10G/3.5MM
ARTHREX, INC.
AR-6655
In Commercial Distribution

  • 00888867184176 ()
AR-6655

  • Manual orthopaedic bender, reusable

Arthrex® - 00888867184107

Univers Revers Humeral Case(2of2)
ARTHREX, INC.
AR-9501HC-2
In Commercial Distribution

  • 00888867184107 ()
AR-9501HC-2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867184091

Univers Revers Humeral Case(1of2)
ARTHREX, INC.
AR-9501HC-1
In Commercial Distribution

  • 00888867184091 ()
AR-9501HC-1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867183827

HOHMANN RETRTR,10 1/2" LGX 24MM BLD,RND
ARTHREX, INC.
AR-9260-35
In Commercial Distribution

  • 00888867183827 ()
AR-9260-35

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867175136

Suture Cutter, Top Release
ARTHREX, INC.
SP-12250-1
In Commercial Distribution

  • 00888867175136 ()
SP-12250-1

  • General-purpose surgical scissors, reusable

Arthrex® - 00888867153172

Hamstring Donor Site Delivery Tube
ARTHREX, INC.
AR-1280-1
In Commercial Distribution

  • 00888867153172 ()
AR-1280-1

  • Orthopaedic graft inserter, reusable

Arthrex® - 00888867141636

Univers Revers Reduction Helper
ARTHREX, INC.
AR-9545
In Commercial Distribution

  • 00888867141636 ()
AR-9545

  • Surgical depth gauge, reusable

Arthrex® - 00888867140370

UNIVERS REVERS SCREW CADDY
ARTHREX, INC.
AR-9501GC-SC
In Commercial Distribution

  • 00888867140370 ()
AR-9501GC-SC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867138513

HOHMANN RETRTR,9.75" LGX 19MM WD BLADE
ARTHREX, INC.
AR-9260-48
In Commercial Distribution

  • 00888867138513 ()
AR-9260-48

  • Hand-held surgical retractor, reusable
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