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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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SURGUARD2 - 34806017512942

SURGUARD2 Safety Hypodermic Needle
TERUMO (PHILIPPINES) CORPORATION
10180094
In Commercial Distribution

  • 54806017512946 ()
  • 34806017512942 ()
  • 14806017512948 ()

  • Needle Gauge: 27 Gauge
  • Length: 0.5 Inch


  • Hypodermic needle, single-use

V.A.C. VERAT.R.A.C. DUO™ - 00849554001312

VAC Veralink Cassette
KCI USA, INC.
ULTLNK0500
In Commercial Distribution

  • 00849554001312 ()
  • 00849554000186 ()
  • 00849554003231 ()


  • Negative-pressure wound therapy tubing set

PREVENA™ PEEL & PLACE™ - 00849554004641

Prevena Peel & Place Dressing- 13 cm
KCI USA, INC.
Prevena Peel & Place Dressing- 13 cm
In Commercial Distribution

  • 00849554004641 ()
  • 00849554004603 ()
  • 00849554005372 ()


  • Negative-pressure wound therapy system, electric, single-use

Persona® - 00889024553095

No Description
Zimmer, Inc.
42-5868-058-05
In Commercial Distribution

  • 00889024553095 ()

  • Sizes 5, 5+, 5 mm
42-5868-058-05

  • Knee femur prosthesis trial, reusable

Persona® - 00889024552906

No Description
Zimmer, Inc.
42-5866-058-05
In Commercial Distribution

  • 00889024552906 ()

  • Sizes 5, 5+, 5 mm
42-5866-058-05

  • Knee femur prosthesis trial, reusable

Conformity stem, collared, #5 - 04711605582988

Conformity stem, collared, #5
UNITED ORTHOPEDIC CORP.
1110-1005
In Commercial Distribution

  • 04711605582988 ()
1110-1005

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

5 Fr Fiber Guide - 00848657075749

No Description
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
LG1620
In Commercial Distribution

  • 00848657075749 ()
LG1620

  • Laparoscopic surgical procedure kit, non-medicated, reusable

Baha 5 Inner Case - 09321502032803

No Description
Cochlear Bone Anchored Solutions AB
95224
In Commercial Distribution

  • 09321502032803 ()
95224

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Power, Copper - 09321502034623

No Description
Cochlear Bone Anchored Solutions AB
95474
In Commercial Distribution

  • 09321502034623 ()
95474

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Power, Brown - 09321502034616

No Description
Cochlear Bone Anchored Solutions AB
95473
In Commercial Distribution

  • 09321502034616 ()
95473

  • Bone-conduction hearing implant system sound processor/vibrator
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