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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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Integra® Freedom Wrist Arthroplasty System - 10381780066965

The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpal implant.
Ascension Orthopedics, Inc.
348215
In Commercial Distribution

  • M2683482151 ()
  • 10381780066965 ()

  • 4.5 mm dia x 15 mm L
348215

  • Total wrist prosthesis

SPIN® - 10381780051879

The Weil clamp is used to hold the oesteotomy in place for correct insertion of the fixation screws.
NEWDEAL
119106ND
In Commercial Distribution

  • M248119106ND1 ()
  • 10381780051879 ()


  • Bone holding forceps

QWIX® - 10381780051404

The hexagonal cannulated graduated screwdriver axis, with AO attachment, is used to implant or explant 4.3mm fixation screws.
NEWDEAL
119114ND
In Commercial Distribution

  • M248119114ND1 ()
  • 10381780051404 ()

  • 6 faces, 2.49mm X 170mm length


  • Surgical screwdriver, reusable

Dehydroepiandrosterone (DHEA) ELISA - B24211HEAHUE010

The Dehydroepiandrosterone ELISA is intended for the direct quantitative determination of DHEA by enzyme immunoassay in human serum.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
11-HEAHU-E01
In Commercial Distribution

  • B24211HEAHUE010 ()
11-HEAHU-E01

  • Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)

PANTA® - 10381780043232

The short protection sleeve is used to guide the drills while preparing the holes for the fixation screws.
NEWDEAL
519184ND
In Commercial Distribution

  • M248519184ND1 ()
  • 10381780043232 ()

  • 7.2mm diam. x 53mm length


  • Surgical drill guide, reusable

PANTA® - 10381780043225

The medium protection sleeve is used to guide the drills while preparing the holes for the fixation screws.
NEWDEAL
519183ND
In Commercial Distribution

  • M248519183ND1 ()
  • 10381780043225 ()

  • 7.2mm diam. x 76mm length


  • Surgical drill guide, reusable

PANTA® - 10381780043201

The long drilling guide is used to guide the drills while preparing the holes for the fixation screws.
NEWDEAL
519180ND
In Commercial Distribution

  • M248519180ND1 ()
  • 10381780043201 ()

  • 4.5mm diam. x 117mm length


  • Surgical drill guide, reusable

PANTA® - 10381780043195

The short drilling guide is used to guide the drills while preparing the holes for the fixation screws.
NEWDEAL
519179ND
In Commercial Distribution

  • M248519179ND1 ()
  • 10381780043195 ()

  • 4.5mm diam. x 71mm length


  • Surgical drill guide, reusable

PANTA® - 10381780043188

The medium drilling guide is used to guide the drills while preparing the holes for the fixation screws.
NEWDEAL
519178ND
In Commercial Distribution

  • M248519178ND1 ()
  • 10381780043188 ()

  • 4.5mm diam. x 94mm length


  • Surgical drill guide, reusable

Integra® TruArch® - 10381780119975

The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot.
Ascension Orthopedics, Inc.
TA1200
Not in Commercial Distribution

  • 10381780119975 ()
  • M268TA12001 ()

  • 18 mm L x 12 mm dia
TA1200

  • Subtalar implant, non-bioabsorbable
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