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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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Catalyst & Universal Paste
KURARAY NORITAKE DENTAL INC.
#315-KA
In Commercial Distribution

  • EKUR000315KA1 ()


  • Dental composite resin
No Description
Dental Imaging Technologies Corporation
1.013.9723
Not in Commercial Distribution

  • EKAV101397230 ()


  • Dental digital imaging sensor, intraoral
No Description
Dental Imaging Technologies Corporation
1.013.9722
Not in Commercial Distribution

  • EKAV101397220 ()


  • Dental digital imaging sensor, intraoral
No Description
Dental Imaging Technologies Corporation
1.013.7049
Not in Commercial Distribution

  • EKAV101370490 ()


  • Dental digital imaging sensor, intraoral
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
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
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
V. Mueller NEW ORLEANS ENDARTERECTOMY STRIPPER SET SIZES 4, 5, 6, 7 AND 9MM ON 12" (30.5CM) HANDLE
CAREFUSION 2200, INC
CH8320
Not in Commercial Distribution

  • 10885403034992 ()
CH8320

  • Intraluminal artery stripper, reusable
Klarity Customized Head and Neck Mold 15cm head area, 59x47 cm with New Neck Flare and 6cm bump.
Klarity Medical Products, LLC
R550-PS47
In Commercial Distribution

  • 00817355027978 ()


  • Patient positioning foam mould kit
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