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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® - 00888867229488

Revers CA Humeral Head, 44/19
ARTHREX, INC.
AR-9544-19RCA
Not in Commercial Distribution

  • 00888867229488 ()
  • M150AR954419RCA1 ()
AR-9544-19RCA

  • Total reverse shoulder prosthesis

Arthrex® - 00888867229471

Revers CA Humeral Head, 44/17
ARTHREX, INC.
AR-9544-17RCA
In Commercial Distribution

  • 00888867229471 ()
  • M150AR954417RCA1 ()
AR-9544-17RCA

  • Total reverse shoulder prosthesis

Arthrex® - 00888867229389

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

  • 10888867229386 ()
  • 00888867229389 ()
AR-1280

  • Orthopaedic graft inserter, reusable

Arthrex® - 00888867229228

SutureTape, 1.3mm w/Needle, White/Blue
ARTHREX, INC.
AR-7500
In Commercial Distribution

  • 00888867229228 ()
  • M150AR75001 ()
  • 10888867229225 ()
AR-7500

  • Polyolefin/fluoropolymer suture, multifilament

Arthrex® - 00888867229198

BioCartilage Kit, Large Joint
ARTHREX, INC.
ABS-1000-L
In Commercial Distribution

  • 00888867229198 ()
  • M150ABS1000L1 ()
ABS-1000-L

  • Bone graft syringe, single-use

Arthrex® - 00888867229181

BioCartilage Kit, Small Joint
ARTHREX, INC.
ABS-1000-S
In Commercial Distribution

  • 00888867229181 ()
  • M150ABS1000S1 ()
ABS-1000-S

  • Bone graft syringe, single-use

Arthrex® - 00888867228214

UNIVERS APEX HUMERAL STEM, SIZE 5
ARTHREX, INC.
AR-9100-05S
In Commercial Distribution

  • 00888867228214 ()
  • M150AR910005S1 ()
AR-9100-05S

  • Total shoulder prosthesis

Arthrex® - 00888867227620

DISPOSABLE KIT, FOR 2.0 HIP SUTURETAK
ARTHREX, INC.
AR-1934DHS-20
In Commercial Distribution

  • 00888867227620 ()
AR-1934DHS-20

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867227613

SUTURE ANCHOR, PEEK, MINI HIP SUTURETAK
ARTHREX, INC.
AR-1934PHS-20
In Commercial Distribution

  • 10888867227610 ()
  • 00888867227613 ()
AR-1934PHS-20

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867227187

SCORPION NEEDLE, HIP LENGTH
ARTHREX, INC.
AR-16991N-1
In Commercial Distribution

  • 00888867227187 ()
AR-16991N-1

  • Suturing unit, single-use
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