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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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BUDDE® Halo Sterilization Case
INTEGRA LIFESCIENCES CORPORATION
438A1096
In Commercial Distribution

  • M268438A10961 ()
  • 10381780255550 ()


  • Neurosurgical retraction system, brain
Integra® BRS Sterilization Case
INTEGRA LIFESCIENCES CORPORATION
417A1010
In Commercial Distribution

  • M268417A10101 ()
  • 10381780253921 ()
417A1010

  • Neurosurgical retraction system, brain
Surgical Insturments, Instrument Case Lid
Ascension Orthopedics, Inc.
CSA00001
In Commercial Distribution

  • M269CSA000011 ()
  • 10381780242918 ()
CSA-000-01

  • Instrument tray, reusable
Case for Cadence Resection Instruments
Ascension Orthopedics, Inc.
CSA-1020-0011
In Commercial Distribution

  • M268CSA102000111 ()
  • 10381780241294 ()

  • 21.20in L x 9.80in W x 3.05in H
CSA-1020-0011

  • Instrument tray, reusable
CW07 CASE WESTERN OPERATIVE 1P
Peter Brasseler Holdings, LLC
5010558U0
In Commercial Distribution

  • 00887919535386 ()


  • Diamond dental bur, single-use
CW05 CASE WESTERN DIAMOND 1P
Peter Brasseler Holdings, LLC
5010556U0
In Commercial Distribution

  • 00887919535362 ()


  • Diamond dental bur, single-use
CW04 CASE WESTERN DENTURE 1P
Peter Brasseler Holdings, LLC
5010555U0
In Commercial Distribution

  • 00887919535355 ()


  • Diamond dental bur, single-use
CW02 CASE WESTERN PROV 1P
Peter Brasseler Holdings, LLC
5010553U0
In Commercial Distribution

  • 00887919535331 ()


  • Diamond dental bur, single-use
Assure Prism Kit (no CASE)
BOUND TREE MEDICAL, LLC
670167-KIT
In Commercial Distribution

  • 00812277031461 ()
670167-KIT

  • Glucose monitoring system IVD, point-of-care
Steripack Surgical Utility Case Generic
Shoulder Innovations, Inc.
Surgical Utility Case Generic
In Commercial Distribution

  • B1132N1KS000150 ()


  • Total shoulder prosthesis
  • Shoulder glenoid fossa prosthesis, prefabricated
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