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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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Acetabular reamer for hip arthroplasty
Incipio Devices SA
9055.IN.061 00
In Commercial Distribution

  • 07630055300683 ()

  • Outer Diameter: 61 Millimeter
9055.IN.061 00

  • Acetabular orthopaedic reamer
GHB 20 MG/L
UTAK LABORATORIES, INC.
GHB 20 U IN
In Commercial Distribution

  • B800GHB20UIN5 ()
  • B800GHB20UIN0 ()

  • Total Volume: 2.5 Milliliter
GHB 20 U IN

  • Gamma-hydroxybutyrate (GHB) IVD, control
PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40
Ascension Orthopedics, Inc.
OSG20040P
In Commercial Distribution

  • M269OSG20040P1 ()
  • 10381780246442 ()

  • Size 40; 1.250 in L x .966 in outer W x .27 in inner W
OSG-200-40P

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 30
Ascension Orthopedics, Inc.
OSG20030P
In Commercial Distribution

  • M269OSG20030P1 ()
  • 10381780246428 ()

  • Size 30; 1.250 in L x .926 in outer W x .25 in inner W
OSG-200-30P

  • Custom-made orthopaedic/craniofacial surgical guide
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
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
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
In Situ Adjuster
K2M, INC.
702-90156
In Commercial Distribution

  • 10888857127784 ()
702-90156

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ELEVATORS BERNARD IN
Power Dental U.S.A. Inc.
3749IN
In Commercial Distribution

  • D9433749IN0 ()
3749IN

  • Dental elevator, tooth/root
IN ROOM KIT
MEDLINE INDUSTRIES, INC.
DYKM1555
In Commercial Distribution

  • 10889942735143 ()
DYKM1555

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