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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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Diamond Orthopedic, LLC - B551DMD311430

Handle with quick-coupling
DIAMOND ORTHOPEDIC, LLC
DMD-311-430
In Commercial Distribution

  • B551DMD311430 ()
DMD-311-430

  • Surgical screwdriver, reusable

Exact Medical Manufacturing, Inc. - 00816953020541

BabyMat with print
EXACT MEDICAL MANUFACTURING, INC.
E2150N
Not in Commercial Distribution

  • 00816953020558 ()
  • 00816953020541 ()
E2150N

  • Patient surgical drape, single-use

Prima - D76845009K0

Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845008K0

Base with Anatite
KEYSTONE DENTAL, INC.
45008K
Not in Commercial Distribution

  • D76845008K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45008K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845007K0

Base with Anatite
KEYSTONE DENTAL, INC.
45007K
Not in Commercial Distribution

  • D76845007K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45007K

  • Dental implant suprastructure, permanent, preformed

Cook - 00827002070097

Dilator with Handle
COOK INCORPORATED
G07009
Not in Commercial Distribution

  • 00827002070097 ()
JCD18.0-38-13.3-H-TCCS

  • Fascial tissue dilator, single-use

Cook - 00827002062627

Dilator with Handle
COOK INCORPORATED
G06262
In Commercial Distribution

  • 00827002062627 ()
JCD12.0-38-7.6-H-TCCS

  • Fascial tissue dilator, single-use

Cook - 00827002062610

Dilator with Handle
COOK INCORPORATED
G06261
In Commercial Distribution

  • 00827002062610 ()
JCD10.0-38-7.1-H-TCCS

  • Fascial tissue dilator, single-use

BioStamp® nPoint - G012BRCA02

Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

Earhook - 00840094452619

Standard with grip
Advanced Bionics, LLC
CI-5710-210
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor earhook
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