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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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Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
Visix software version 2.3.9
TELEVERE SYSTEMS, LLC
2.3.9
In Commercial Distribution

  • 00851800007030 ()
Visix 2.3.9

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
HF-cable, monopolar, 3.5 m, UES-30, Erbe Intl. and Valleylab (new) HF-unit to 3 mm pin surgical instrument
OLYMPUS Winter & Ibe GmbH
A0335.1
In Commercial Distribution

  • 04042761001465 ()
A0335.1

  • Electrical-only medical device connection cable, reusable
IPV2-C, Spanish, Dual Gas, DISS-OXY, NIST-AIR, Spain (New variation; product line discontinued in EU before product launch.)
PERCUSSIONAIRE CORPORATION
F00002-C
Not in Commercial Distribution

  • 10849436000737 ()
  • 00849436000730 ()
S00003-C-ES

  • Portable pneumatic high-frequency ventilator
Graftgun Universal Graft Delivery System - Cartridge Kit labeled with new catalog number for distribution by Integrity Implants
SURGENTEC, LLC
IG-K-1000
In Commercial Distribution

  • 00858406007433 ()


  • Orthopaedic cement dispenser
Infant Single-Patient Size #5, Circ: 10.0 - 15.0 cm, incorporates the new connector configuration, 40 cuffs per box.
Philips Medical Systems Hsg
INFANT SINGLE-PATIENT CUFF SIZE #5
Not in Commercial Distribution

  • 20884838008575 ()
  • 00884838008571 ()

  • Circumference: 15 Centimeter
M1873B

  • Blood pressure cuff, reusable
No Description
Dentsply International Inc.
87 U A26
Not in Commercial Distribution

  • D00115116U87A260 ()
15116

  • Resin artificial teeth
No Description
Dentsply International Inc.
87 U A25
Not in Commercial Distribution

  • D00115116U87A250 ()
15116

  • Resin artificial teeth
No Description
Dentsply International Inc.
87 U A24
Not in Commercial Distribution

  • D00115116U87A240 ()
15116

  • Resin artificial teeth
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