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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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10% PVP Solution with HSA - 00810195240132

Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 10% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90123-5x0.5ML
In Commercial Distribution

  • 00810195240132 ()
90123

  • IVF medium

Slide Hammer with Threaded Tip - 00887868480911

No Description
Biomet Orthopedics, LLC
31-473621
In Commercial Distribution

  • 00887868480911 ()
31-473621

  • Surgical mallet

7% PVP Solution with HSA - 00810195240125

Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90121-5x0.5ML
In Commercial Distribution

  • 00810195240125 ()
90121

  • IVF medium

J Hook non-stick with cable - B354OSJHOOK335C0

J Hook non-stick with cable
ORANGE SURGICAL INSTRUMENTS, LLC
OSJHOOK335C
Not in Commercial Distribution

  • B354OSJHOOK335C10 ()
  • B354OSJHOOK335C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

Lap-port closure device with swabs - B354OSLPCDS0

Lap-port closure device with swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B354OSLPCDS0 ()
OSLPCDS

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread

L Hook non-stick with cable - B354OSLHOOK445C0

L Hook non-stick with cable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLHOOK445C
Not in Commercial Distribution

  • B354OSLHOOK445C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

F.A.S.T. PEG DRIVER WITH AO - 00887868071676

No Description
Biomet Orthopedics, LLC
FPD40
In Commercial Distribution

  • 00887868071676 ()

  • 4.0MM
FPD40

  • Surgical screwdriver, reusable

SMALL HEX SCREWDRIVER WITH GROOVE - 00887868068683

No Description
Biomet Orthopedics, LLC
939999569
In Commercial Distribution

  • 00887868068683 ()
939999569

  • Surgical screwdriver, reusable

HANDLE WITH MINI QUICK COUPLING - 00887868068461

No Description
Biomet Orthopedics, LLC
939999468
In Commercial Distribution

  • 00887868068461 ()
939999468

  • Surgical instrument handle, non-torque-limiting

PERPOS PLS Instruments with Tray - 81195401009648

Instrument kit contains quantity of 1 each: Perpos 2 in 1 Drill, Perpos K-Wire, Perpos Pull Pin Remover, Perpos Tap, Perpos Device Driver, Perpos Compression Tool, Tray Assembly
INTERVENTIONAL SPINE, INC
9039-02
Not in Commercial Distribution

  • 81195401009648 ()
9039-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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