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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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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
3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative New User Kit for CEREC™ Owners, 2914CN
3M COMPANY
2914CN
In Commercial Distribution

  • 30605861048133 ()
2914CN

  • Resin dental inlay
3M™ ESPE™ Sinfony™ Deluxe Set, 69400
3M Deutschland GmbH
69400
In Commercial Distribution

  • J001702011438180 ()
69400

  • Dentine bonding agent/set
  • Denture reliner, hard
3M™ ESPE™ Sinfony™ Deluxe Set, 69400
3M Deutschland GmbH
69400
In Commercial Distribution

  • 04035077009737 ()
69400

  • Denture reliner, hard
  • Dentine bonding agent/set
10MM, 32CM, IRRIGATION / SUCTION TUBE FOR DISPOSABLE HANDLES, REGULAR TIP-VENTED, STAINLESS STEEL, FINISH, CONMED NEW TWIST AND LOCK HANDLE
ELMED INCORPORATED
52832-404JC
In Commercial Distribution

  • 00198506058813 ()
52832-404JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable
Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)
PARKELL, INC.
D631ADAPT
In Commercial Distribution

  • 00810000520466 ()
D631ADAPT

  • Dental pulp analysis system
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