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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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Fusion™ Anterior Instrument Set - 00846468036669

SPREADER CASE
Pioneer Surgical Technology, Inc.
34-SPREADCASE
Not in Commercial Distribution

  • 00846468036669 ()
34-SPREADCASE

  • General internal orthopaedic fixation system implantation kit

CONTACT® IBF PEEK VBR/IBF SYSTEM - 00846468036522

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
34-CASE
Not in Commercial Distribution

  • 00846468036522 ()
34-CASE

  • Device sterilization/disinfection container, reusable

Fusion™ Anterior Instrument Set - 00846468036515

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
34-ANTFUSION
Not in Commercial Distribution

  • 00846468036515 ()
34-ANTFUSION

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK VBR/IBF SYSTEM - 00846468034511

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
32-CASE
Not in Commercial Distribution

  • 00846468034511 ()


  • General internal orthopaedic fixation system implantation kit

C-Plus™ PEEK VBR/IBF System - 00846468031497

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
30-C-CASE
Not in Commercial Distribution

  • 00846468031497 ()


  • General internal orthopaedic fixation system implantation kit

X-PAC - 00850001720151

Delivery Case
EXPANDING INNOVATIONS, INC.
EI2464
In Commercial Distribution

  • 00850001720151 ()
EI2464

  • Instrument tray, reusable

CO-Pilot™ Wireless Handheld Multi-Parameter System - 00849686051032

Carrying Case
NONIN MEDICAL, INC.
H500-CC
In Commercial Distribution

  • 00849686051032 ()
114079-001

  • Pulse oximeter

Duckworth & Kent - 05055313825616

Component Case
DUCKWORTH AND KENT LIMITED
6-139
Not in Commercial Distribution

  • 05055313825616 ()
6-139

  • Instrument tray, reusable

CARDINAL HEALTH - 10888439927290

BREAST CASE
Cardinal Health 200, LLC
SBA53BRPR4
In Commercial Distribution

  • 50888439927298 ()
  • 10888439927290 ()
SBA53BRPR4

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439966213

BREAST CASE
Cardinal Health 200, LLC
SBA53BRPR5
In Commercial Distribution

  • 50888439966211 ()
  • 10888439966213 ()
SBA53BRPR5

  • General surgical procedure kit, non-medicated, single-use

Valencia Pedicle Screw System - 00843210134659

Auxiliary Case
Altus Spine, LLC
908-1203
In Commercial Distribution

  • 00843210134659 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

CARDINAL HEALTH - 10888439179026

BREAST CASE
Cardinal Health 200, LLC
SBA53BRPR2
In Commercial Distribution

  • 50888439179024 ()
  • 10888439179026 ()
SBA53BRPR2

  • General surgical procedure kit, non-medicated, single-use

Juveno™ Femoral Hip System - 00843575104113

Sterilization Case
B-ONE ORTHO, CORP.
8819900100
In Commercial Distribution

  • 00843575104113 ()
8819900100

  • Surgical instrument/implant rack

CARDINAL HEALTH - 10888439213102

BREAST CASE
Cardinal Health 200, LLC
SBA53BRPR3
In Commercial Distribution

  • 50888439213100 ()
  • 10888439213102 ()
SBA53BRPR3

  • General surgical procedure kit, non-medicated, single-use

EcoLotion - 00628055650836

12x250ml case
Eco-Med Pharmaceutical Inc
85CBB
In Commercial Distribution

  • 00628055650836 ()


  • Skin topical coupling gel

EcoLotion - 00628055650829

24x250ml case
Eco-Med Pharmaceutical Inc
85CB
In Commercial Distribution

  • 00628055650829 ()


  • Skin topical coupling gel

Tornier Humeral Nail - 00846832021208

Case Lid
TORNIER, INC.
9020005
In Commercial Distribution

  • 00846832021208 ()
9020005

  • Instrument tray, reusable

Tornier Humeral Nail - 00846832016983

Case Lid
TORNIER, INC.
DHN5814
In Commercial Distribution

  • 00846832016983 ()
DHN5814

  • Instrument tray, reusable

Tornier Humeral Nail - 00846832016976

Case Base
TORNIER, INC.
DHN5813
In Commercial Distribution

  • 00846832016976 ()
DHN5813

  • Instrument tray, reusable

Futura CSI - 00846832016648

Case Lid
TORNIER, INC.
CSI2-LID
In Commercial Distribution

  • 00846832016648 ()
CSI2-LID

  • Instrument tray, reusable
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