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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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Cervical Drill Revision with Stop L09 - B806GN0091D2090

Cervical Drill Revision with Stop L09
Spineup, Inc.
GN0091D209
In Commercial Distribution

  • B806GN0091D2090 ()
GN0091D209

  • Fluted surgical drill bit, reusable

Cervical Drill Primary with Stop L22 - B806GN0084D1220

Cervical Drill Primary with Stop L22
Spineup, Inc.
GN0084D122
In Commercial Distribution

  • B806GN0084D1220 ()
GN0084D122

  • Fluted surgical drill bit, reusable

Cervical Drill Primary with Stop L21 - B806GN0083D1210

Cervical Drill Primary with Stop L21
Spineup, Inc.
GN0083D121
In Commercial Distribution

  • B806GN0083D1210 ()
GN0083D121

  • Fluted surgical drill bit, reusable

Cervical Tap Primary with Stop L11 - B806GN0053T1110

Cervical Tap Primary with Stop L11
Spineup, Inc.
GN0053T111
In Commercial Distribution

  • B806GN0053T1110 ()
GN0053T111

  • Bone tap, reusable

Cervical Tap Primary with Stop L10 - B806GN0052T1100

Cervical Tap Primary with Stop L10
Spineup, Inc.
GN0052T110
In Commercial Distribution

  • B806GN0052T1100 ()
GN0052T110

  • Bone tap, reusable

Cervical Tap Primary with Stop L08 - B806GN0050T1080

Cervical Tap Primary with Stop L08
Spineup, Inc.
GN0050T108
In Commercial Distribution

  • B806GN0050T1080 ()
GN0050T108

  • Bone tap, reusable

Romero Cervical Screw Remover - B806GN0010SRZZ0

Cervical Screw Remover
Spineup, Inc.
GN0010SRZZ
In Commercial Distribution

  • B806GN0010SRZZ0 ()
GN0010SRZZ

  • Screw extractor, reusable

Meditherm - B7837045001705011237

No Description
Meditherm Incorporated
IRIS 450
In Commercial Distribution

  • B7837045001705011237 ()
1704500

  • Infrared thermography system

Stoma-Gel™ - 10850009091052

Stoma-Gel™ pads are hypoallergenic and made from a medical grade, mineral oil-based gel. Stoma-Gel™ pads are a super soft barrier between the tracheostomy tube flange and sterile gauze. The pads unique cushioning material to help increase comfort and decrease soreness, marks, and wounds around the tracheostomy stoma area. One size fits most - slight cut can be made to fit size 9 tracheostomy tubes or larger. No adhesives necessary. Easy to clean with mild soap and water. Air dry.
J.R.J. MEDICAL INNOVATIONS, LLC
JRJ 42501
In Commercial Distribution

  • 30850009091056 ()
  • 10850009091052 ()

  • Length: 73 Millimeter
  • Width: 47 Millimeter
  • Height: 3 Millimeter
JRJ 42501

  • Removable ambulatory appliance skin-adherent patch

Safe-T-Surg - 10865082000167

Safe-T-Surg Retractor
BihlerMed, L.L.C.
2804-01-0001
In Commercial Distribution

  • 20865082000164 ()
  • 10865082000167 ()
  • 00865082000160 ()


  • Surgical retractor/retraction system blade, reusable
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