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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® - 10381780246404

PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 20
Ascension Orthopedics, Inc.
OSG20020P
In Commercial Distribution

  • M269OSG20020P1 ()
  • 10381780246404 ()

  • Size 20; 1.250 in L x .879 in outer W x .23 in inner W
OSG-200-20P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246381

PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 10
Ascension Orthopedics, Inc.
OSG20010P
In Commercial Distribution

  • M269OSG20010P1 ()
  • 10381780246381 ()

  • Size 10; 1.225 in L x .814 in outer W x .19 in inner W
OSG-200-10P

  • Custom-made orthopaedic/craniofacial surgical guide

Symmetry Surgical® - 00887482049860

Speculum, Sims Vaginal, Double-Ended, #1, 1 in x 2 3/4 in x 1 1/8 in x 3 in
SYMMETRY SURGICAL INC.
52-2001
Not in Commercial Distribution

  • 00887482049860 ()
52-2001

  • Vaginal speculum, reusable

ALEUTIAN Interbody Systems - 10888857127784

In Situ Adjuster
K2M, INC.
702-90156
In Commercial Distribution

  • 10888857127784 ()
702-90156

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Power Dental USA - D9433749IN0

ELEVATORS BERNARD IN
Power Dental U.S.A. Inc.
3749IN
In Commercial Distribution

  • D9433749IN0 ()
3749IN

  • Dental elevator, tooth/root

Medline Industries, Inc. - 10889942735143

IN ROOM KIT
MEDLINE INDUSTRIES, INC.
DYKM1555
In Commercial Distribution

  • 10889942735143 ()
DYKM1555

  • General surgical procedure kit, non-medicated, single-use

MORRISON MEDICAL - 00647921670006

HEAD IN POUCH
MORRISON MEDICAL, LTD
6700
In Commercial Distribution

  • 00647921670006 ()
6700

  • General-purpose patient lifting system sling/harness

EVEREST Spinal System - 10888857181304

Goniometer In Situ
K2M, INC.
2901-90142
In Commercial Distribution

  • 10888857181304 ()
2901-90142

  • General-purpose calliper, metallic

NA - 10705034771922

IN SITU BENDER-LEFT
Synthes GmbH
388.113
In Commercial Distribution

  • 07611819824997 ()
  • H9813881130 ()
  • 10705034771922 ()
388113

  • Manual orthopaedic bender, reusable

NA - 10705034771915

IN SITU BENDER-RIGHT
Synthes GmbH
388.112
In Commercial Distribution

  • 07611819824980 ()
  • H9813881120 ()
  • 10705034771915 ()
388112

  • Manual orthopaedic bender, reusable
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