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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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Mendez Degree Gauge With Fixation - 08175700105583

Mendez Degree Gauge With Fixation
AURORA SURGICAL, LLC
AS1-355
In Commercial Distribution

  • 08175700105583 ()
AS1-355

  • Eyeball fixation instrument, reusable

Ernest Nucleus Cracker, with Serrations - 08175700137003

Ernest Nucleus Cracker, with Serrations
AURORA SURGICAL, LLC
AS9-001
In Commercial Distribution

  • 08175700137003 ()
AS9-001

  • Eye muscle hook, reusable

Shephard IOL Forceps With Lock - 08175700132145

Shephard IOL Forceps With Lock
AURORA SURGICAL, LLC
AS7-652
In Commercial Distribution

  • 08175700132145 ()
AS7-652

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Vial Spike with Needle-Free Valve - 10816203020281

Vial spike with needle-free valve, pack of 10
ORIGEN BIOMEDICAL, INC.
VSV
In Commercial Distribution

  • 20816203020288 ()
  • 10816203020281 ()


  • Blood transfer set

mBrace Wrist Support with Clip - 10815614020163

The mBrace Model 4275 is a wrist support device that extends the patient's wrist at a consistent 40°angle with a syringe clip to attach a syringe.
Semler Technologies, Inc.
4275
In Commercial Distribution

  • 20815614020160 ()
  • 10815614020163 ()
140-0275-00

  • Wrist immobilizer, single-use

mBrace Wrist Support with Hook - 10815614020156

The mBrace Model 4250 is a wrist support device that extends the patient's wrist at a consistent 40°angle with a hook to integrate with an ArmBoard.
Semler Technologies, Inc.
4250
In Commercial Distribution

  • 20815614020153 ()
  • 10815614020156 ()
140-0250-00

  • Wrist immobilizer, single-use

OPTION, SILHOUETTE SCANBOARD WITH TARGET - 10815411020557

No Description
NEUROLOGICA CORP.
0-00135-002
In Commercial Distribution

  • 10815411020557 ()


  • Head/neck procedure positioner

Bipolar Instrument Handle with Lock - 10815288013898

No Description
ENCISION, INC.
BP7200L
In Commercial Distribution

  • 10815288013898 ()
BP7200L

  • Electrosurgical handpiece, reusable

CORFLO PEG Kit with snare - 10815149025350

PEG Safety Kit Push Technique
CORPAK MEDSYSTEMS, INC.
30-4320-S7
In Commercial Distribution

  • 20815149025357 ()
  • 10815149025350 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4320-S7

  • Ultraviolet phototherapy unit, professional

CORFLO PEG Kit with snare - 10815149025343

PEG Kit Push Technique; with snare
CORPAK MEDSYSTEMS, INC.
30-4020-S7
In Commercial Distribution

  • 20815149025340 ()
  • 10815149025343 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4020-S7

  • Ultraviolet phototherapy unit, professional
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