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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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Integra® - 10381780080244

Integra® Freer Septum Knife, E Model
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3714432
In Commercial Distribution

  • 10381780080244 ()

  • 6-1/2"
3714432

  • Nasal knife

BOSS Instruments - 00888515203433

Spatula & Packer, 5 3/4" D/E
BOSS INSTRUMENTS, LTD., INC.
78-2008
In Commercial Distribution

  • 00888515203433 ()
78-2008

  • Open-surgery dissector

Elecsys proBNP II Immunoassay - 07613336191569

proBNP G2 Elecsys cobas e 100 V2.1
Roche Diagnostics GmbH
09315268160
In Commercial Distribution

  • 07613336191569 ()
09315268160

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Confirmatory Test - 07613336175293

HBsAg Confirmatory Test Elecsys cobas e V2
Roche Diagnostics GmbH
09127127190
In Commercial Distribution

  • 07613336175293 ()
09127127190

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Elecsys Testosterone II - 07613336170557

Testosterone G2 Elecsys cobas e 100 V2
Roche Diagnostics GmbH
08946353190
In Commercial Distribution

  • 07613336170557 ()
08946353190

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Integra® - 10381780074571

Integra® E/Z Chuck Blade Handle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1352321
In Commercial Distribution

  • 10381780074571 ()

  • 4-1/8"
1352321

  • Scalpel handle, reusable

Mpact Acetabular System - 07630030812118

Flat PE HC liner Ø 36 / E
Medacta International SA
01.32.3644HCT
In Commercial Distribution

  • 07630030812118 ()


  • Non-constrained polyethylene acetabular liner

Mpact Acetabular System - 07630030812101

Hooded PE HC Liner Ø 36 / E
Medacta International SA
01.32.3644HCAT
In Commercial Distribution

  • 07630030812101 ()


  • Non-constrained polyethylene acetabular liner

Mpact Acetabular System - 07630030811654

Flat PE HC liner Ø 28 / E
Medacta International SA
01.32.2844HCT
In Commercial Distribution

  • 07630030811654 ()


  • Non-constrained polyethylene acetabular liner

Mpact Acetabular System - 07630030811647

Hooded PE HC Liner Ø 28 / E
Medacta International SA
01.32.2844HCAT
In Commercial Distribution

  • 07630030811647 ()


  • Non-constrained polyethylene acetabular liner
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