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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® - 00888867107335

iBALANCE TKA, BEARING IMP, PS, SZ 5, 8MM
ARTHREX, INC.
AR-513-BF08
In Commercial Distribution

  • 00888867107335 ()
  • M150AR513BF081 ()
AR-513-BF08

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

Surgical Direct - B382SD907212040

5 1/2 Inch Cottle Retractor, 4 Prong
Surgical Direct, Inc.
SD90721204
In Commercial Distribution

  • B382SD907212040 ()
SD90721204

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD907074020

5 inch Guthrie Fixation Hook, 2mm Tip, Large
Surgical Direct, Inc.
SD90707402
In Commercial Distribution

  • B382SD907074020 ()
SD90707402

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD9057020400

5 3/4" Reverdin Suture Needle, #4, Curved
Surgical Direct, Inc.
SD905702040
In Commercial Distribution

  • B382SD9057020400 ()
SD905702040

  • Suturing needle holder, reusable

Surgical Direct - B382SD905700040

5 1/2 inch Reverdin Needle, Strong Curve
Surgical Direct, Inc.
SD90570004
In Commercial Distribution

  • B382SD905700040 ()
SD90570004

  • Suturing needle holder, reusable

Surgical Direct - B382SD905700020

5 1/2 inch Reverdin Needle, Slight Curve
Surgical Direct, Inc.
SD90570002
In Commercial Distribution

  • B382SD905700020 ()
SD90570002

  • Suturing needle holder, reusable

Surgical Direct - B382SD905685100

8 5/8" D'Errico Cup Forceps, 2mm, Bayonet
Surgical Direct, Inc.
SD90568510
In Commercial Distribution

  • B382SD905685100 ()
SD90568510

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD905662140

5 1/2 inch Castroviejo Needle Holder, Straight
Surgical Direct, Inc.
SD90566214
In Commercial Distribution

  • B382SD905662140 ()
SD90566214

  • Suturing needle holder, reusable

Surgical Direct - B382SD905490140

5" Gillies Needle Holder, Serrated, Offset Design, TC
Surgical Direct, Inc.
SD90549014
In Commercial Distribution

  • B382SD905490140 ()
SD90549014

  • Suturing needle holder, reusable

Surgical Direct - B382SD905438140

5 1/2 inch Microvascular Needle Holder, TC
Surgical Direct, Inc.
SD90543814
In Commercial Distribution

  • B382SD905438140 ()
SD90543814

  • Suturing needle holder, reusable
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