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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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INSTRUMENTATION TRAY - LID ROMEO®
SpineArt SA
ELL-BX 10 02-N
In Commercial Distribution

  • 07640450866615 ()
ELL-BX 10 02-N

  • Instrument tray, reusable
No Description
Vista Dental
90635
In Commercial Distribution

  • 00818207020734 ()


  • Dentine bonding agent/set
Diamond-coated tip for the finishing of the access cavity and the removal of dentinal
EDGE ENDO LLC
ET18D
In Commercial Distribution

  • 00818365020157 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior
EDGE ENDO LLC
AS3D2
In Commercial Distribution

  • 00818365020102 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Romeo 2 Optionnal Rack
SpineArt SA
ROM-BX 10 03-N
In Commercial Distribution

  • 07640185342446 ()
ROM-BX 10 03-N

  • Surgical instrument/implant rack
Instrument container Romeo Navigation
SpineArt SA
NAV-BX 10 01-N
In Commercial Distribution

  • 07640185342439 ()
NAV-BX 10 01-N

  • Instrument tray, reusable
Nav. Drill Sleeve
SpineArt SA
NAV-IN 20 02-N
In Commercial Distribution

  • 07640185341456 ()
NAV-IN 20 02-N

  • Orthopaedic implantation sleeve, reusable
SETSCREW STARTER, LONG
SpineArt SA
SPE-US 00 15-N
In Commercial Distribution

  • 07640185340916 ()
SPE-US 00 15-N

  • Surgical screwdriver, reusable
Instrument container
SpineArt SA
ROM-BX 10 01-N
In Commercial Distribution

  • 07640185341715 ()
ROM-BX 10 01-N

  • Instrument tray, reusable
Stryker Series 7 Power Adapter
SpineArt SA
ROM-BX 70 01-N
In Commercial Distribution

  • 07640185341708 ()
ROM-BX 70 01-N

  • Instrument tray, reusable
BMET-11-2, 2% LIDOCAINE PN 74246-01M
RANFAC CORP.
11GAUGE x 4"
In Commercial Distribution

  • M9797424601M9 ()
  • M9797424601M1 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
BMET-11-2

  • Bone marrow biopsy procedure kit
For use as a cleaning solution on automated analyzers. 6 x 25 ml
Medtest Dx, Inc.
09W500
In Commercial Distribution

  • 00817439020079 ()
09W500

  • Wash/cleaning solution IVD, automated/semi-automated system
MAGNUM ADAMANTA 2 - Cylinder 5 PLS - 1Kg - Jar1 - NLM - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612201052 ()


  • Dental casting non-noble alloy
RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER
ACCLARENT, INC.
RV02
In Commercial Distribution

  • 20705031205878 ()
  • 10705031205871 ()
RV02

  • Paranasal sinus irrigation catheter
Eyer 2 Basic
PHELCOM TECHNOLOGIES SA
Eyer 2 Basic
In Commercial Distribution

  • 07908616100097 ()


  • Ophthalmic fundus camera
U3L .022 +7/+5/0 STD TQ
ORMCO CORPORATION
497-6581
In Commercial Distribution

  • 00889989005462 ()
  • 10889989005469 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
U3R .022 +7/+5/0 STD TQ
ORMCO CORPORATION
497-6580
In Commercial Distribution

  • 00889989005455 ()
  • 10889989005452 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
U3L .022 +7/+5/0 STD TQ HK
ORMCO CORPORATION
497-7581
In Commercial Distribution

  • 00889989000627 ()
  • 10889989000624 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
U3R .022 +7/+5/0 STD TQ HK
ORMCO CORPORATION
497-7580
In Commercial Distribution

  • 00889989000610 ()
  • 10889989000617 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
U2L .022 +6/+9/0 STD TQ
ORMCO CORPORATION
497-6571
In Commercial Distribution

  • 00889989000603 ()
  • 10889989000600 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
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