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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® - 10381780255550

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

  • M268438A10961 ()
  • 10381780255550 ()


  • Neurosurgical retraction system, brain

Integra® - 10381780253921

Integra® BRS Sterilization Case
INTEGRA LIFESCIENCES CORPORATION
417A1010
In Commercial Distribution

  • M268417A10101 ()
  • 10381780253921 ()
417A1010

  • Neurosurgical retraction system, brain

Integra® - 10381780242918

Surgical Insturments, Instrument Case Lid
Ascension Orthopedics, Inc.
CSA00001
In Commercial Distribution

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

  • Instrument tray, reusable

Cadence™ - 10381780241294

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

Brasseler USA - 00887919535386

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

  • 00887919535386 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919535362

CW05 CASE WESTERN DIAMOND 1P
Peter Brasseler Holdings, LLC
5010556U0
In Commercial Distribution

  • 00887919535362 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919535355

CW04 CASE WESTERN DENTURE 1P
Peter Brasseler Holdings, LLC
5010555U0
In Commercial Distribution

  • 00887919535355 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919535331

CW02 CASE WESTERN PROV 1P
Peter Brasseler Holdings, LLC
5010553U0
In Commercial Distribution

  • 00887919535331 ()


  • Diamond dental bur, single-use

Curaplex - 00812277031461

Assure Prism Kit (no CASE)
BOUND TREE MEDICAL, LLC
670167-KIT
In Commercial Distribution

  • 00812277031461 ()
670167-KIT

  • Glucose monitoring system IVD, point-of-care

Shoulder Innovations TSA - B1132N1KS000150

Steripack Surgical Utility Case Generic
Shoulder Innovations, Inc.
Surgical Utility Case Generic
In Commercial Distribution

  • B1132N1KS000150 ()


  • Total shoulder prosthesis
  • Shoulder glenoid fossa prosthesis, prefabricated

CUSA® Excel - 10381780031628

CUSA® Excel Sterilizer case
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C2636
In Commercial Distribution

  • 10381780031628 ()

  • 36kHz Ultrasonic Frequency x 54.6cm (21.5in) length x 25.4cm (21.5in) width x 12.7cm (5in) depth
C2636

  • Device sterilization/disinfection container, reusable

CUSA® Excel - 10381780031611

CUSA® Excel Sterilizer case
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C2623
In Commercial Distribution

  • 10381780031611 ()

  • 23kHz Ultrasonic Frequency x 54.6cm (21.5in) length x 25.4cm (21.5in) width x 12.7cm (5in) depth
C2623

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844372

Implant and Instrument Case 240x105mm
Medartis AG
A-6710
In Commercial Distribution

  • 07630037844372 ()
A-6710

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844334

Implant and Instrument Case 120x105mm
Medartis AG
A-6709
In Commercial Distribution

  • 07630037844334 ()
A-6709

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844327

Implant and Instrument Case 240x156mm
Medartis AG
A-6706
In Commercial Distribution

  • 07630037844327 ()
A-6706

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844310

Implant and Instrument Case 120x88mm
Medartis AG
A-6705
In Commercial Distribution

  • 07630037844310 ()
A-6705

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844303

Instrument Case APTUS headedCCS 7.0
Medartis AG
A-6603.781
In Commercial Distribution

  • 07630037844303 ()
A-6603.781

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844297

Implant Case APTUS headedCCS 7.0
Medartis AG
A-6603.761
In Commercial Distribution

  • 07630037844297 ()
A-6603.761

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844273

Instrument Case APTUS headedCCS 5.0
Medartis AG
A-6603.581
In Commercial Distribution

  • 07630037844273 ()
A-6603.581

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844266

Implant Case APTUS headedCCS 5.0
Medartis AG
A-6603.561
In Commercial Distribution

  • 07630037844266 ()
A-6603.561

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844242

Instrument Case APTUS headedCCS 4.0
Medartis AG
A-6603.481
In Commercial Distribution

  • 07630037844242 ()
A-6603.481

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844235

Implant Case APTUS headedCCS 4.0
Medartis AG
A-6603.461
In Commercial Distribution

  • 07630037844235 ()
A-6603.461

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844211

Instrument Case APTUS CCS 4.0
Medartis AG
A-6603.431
In Commercial Distribution

  • 07630037844211 ()
A-6603.431

  • Device sterilization/disinfection container, reusable

APTUS - 07630037844204

Implant Case APTUS CCS 4.0
Medartis AG
A-6603.411
In Commercial Distribution

  • 07630037844204 ()
A-6603.411

  • Device sterilization/disinfection container, reusable

APTUS - 07630037831891

Instrument Case APTUS Foot 3.5
Medartis AG
A-6601.062
In Commercial Distribution

  • 07630037831891 ()
A-6601.062

  • Device sterilization/disinfection container, reusable

APTUS - 07630037831846

Implant and Instrument Case 240x88mm
Medartis AG
A-6708
In Commercial Distribution

  • 07630037831846 ()
A-6708

  • Device sterilization/disinfection container, reusable

APTUS - 07630037830504

Template Case APTUS Clavicle 2.8
Medartis AG
A-6606.051
In Commercial Distribution

  • 07630037830504 ()
A-6606.051

  • Device sterilization/disinfection container, reusable

APTUS - 07630037830481

Template Case APTUS Clavicle 2.8
Medartis AG
A-6606.052
In Commercial Distribution

  • 07630037830481 ()
A-6606.052

  • Device sterilization/disinfection container, reusable

APTUS - 07630037830146

Implant Case APTUS Radius Plates
Medartis AG
A-6602.088
In Commercial Distribution

  • 07630037830146 ()
A-6602.088

  • Device sterilization/disinfection container, reusable

APTUS - 07630037830115

Implant Case APTUS Radius Plates
Medartis AG
A-6602.087
In Commercial Distribution

  • 07630037830115 ()
A-6602.087

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829737

Implant Case APTUS Radius Plates
Medartis AG
A-6602.094
In Commercial Distribution

  • 07630037829737 ()
A-6602.094

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829720

Implant Case APTUS Radius Plates
Medartis AG
A-6602.093
In Commercial Distribution

  • 07630037829720 ()
A-6602.093

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829713

Implant Case APTUS Radius Plates
Medartis AG
A-6602.092
In Commercial Distribution

  • 07630037829713 ()
A-6602.092

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829706

Implant Case APTUS Radius Plates
Medartis AG
A-6602.091
In Commercial Distribution

  • 07630037829706 ()
A-6602.091

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829690

Implant Case APTUS Radius Plates
Medartis AG
A-6602.090
In Commercial Distribution

  • 07630037829690 ()
A-6602.090

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829683

Implant Case APTUS Radius Plates
Medartis AG
A-6602.089
In Commercial Distribution

  • 07630037829683 ()
A-6602.089

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829676

Implant Case APTUS Radius Plates
Medartis AG
A-6602.086
In Commercial Distribution

  • 07630037829676 ()
A-6602.086

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829515

Instrument Case APTUS Ankle 3.5
Medartis AG
A-6608.017
In Commercial Distribution

  • 07630037829515 ()
A-6608.017

  • Device sterilization/disinfection container, reusable

APTUS - 07630037829492

Instrument Case APTUS Ankle 2.8
Medartis AG
A-6608.015
In Commercial Distribution

  • 07630037829492 ()
A-6608.015

  • Device sterilization/disinfection container, reusable

APTUS - 07630037828266

Implant Case APTUS Foot Wedges
Medartis AG
A-6601.072
In Commercial Distribution

  • 07630037828266 ()
A-6601.072

  • Device sterilization/disinfection container, reusable

MODUS - 07630037814894

Implant and Instrument Case 240x54mm
Medartis AG
M-6725
In Commercial Distribution

  • 07630037814894 ()
M-6725

  • Device sterilization/disinfection container, reusable

MODUS - 07630037814887

Implant and Instrument Case 240x37mm
Medartis AG
M-6724
In Commercial Distribution

  • 07630037814887 ()
M-6724

  • Device sterilization/disinfection container, reusable

MODUS - 07630037814863

Implant and Instrument Case 120x54mm
Medartis AG
M-6723
In Commercial Distribution

  • 07630037814863 ()
M-6723

  • Device sterilization/disinfection container, reusable

MODUS - 07630037814856

Implant and Instrument Case 120x37mm
Medartis AG
M-6722
In Commercial Distribution

  • 07630037814856 ()
M-6722

  • Device sterilization/disinfection container, reusable

Canaveral® - B183180040020

Tray, Deformity Implant Case 1
FLOSPINE LLC
Canaveral®
In Commercial Distribution

  • B183180040020 ()
01-7000-012

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Canaveral® - B183180040010

Base, Deformity Implant Case 1
FLOSPINE LLC
Canaveral®
In Commercial Distribution

  • B183180040010 ()
01-7000-011

  • Abdominal/ENT/orthopaedic surgical probe, reusable

M6-C - 00812388031312

M6-C Implant Case Kit – Ancillary
Spinal Kinetics, Inc.
FG 0169
In Commercial Distribution

  • 00812388031312 ()
ICC-0000-10

  • Cervical total intervertebral disc prosthesis, modular

M6-C - 00812388031305

M6-C Implant Case Kit – Standard
Spinal Kinetics, Inc.
FG 0168
In Commercial Distribution

  • 00812388031305 ()
ICC-0000-20

  • Cervical total intervertebral disc prosthesis, modular

APTUS - 07630037855125

Instrument Case for MTP Reamers
Medartis AG
A-6622
In Commercial Distribution

  • 07630037855125 ()
A-6622

  • Device sterilization/disinfection container, reusable

APTUS - 07630037854906

Instrument Case APTUS Ankle 3.5
Medartis AG
A-6608.017
In Commercial Distribution

A-6608.017

  • Device sterilization/disinfection container, reusable
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