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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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PLANNING STATION - ROSA ONE - USA - 00889024671102

Planning Station DELL 7520 Qwerty power plug B for Rosa One
MEDTECH
164017-02
In Commercial Distribution

  • 00889024671102 ()


  • Multi-purpose stereotactic surgery system

Integra® Miltex® - 10381780462200

Luxating Elevator Kit, Set of 8: C2 - C5 and S2 - S5, With Cassette
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DELLUXKIT
Not in Commercial Distribution

  • H834DELLUXKIT1 ()
  • 10381780462200 ()
DELLUXKIT

  • Dental elevator, tooth/root

DJO SURGICAL - 00888912440998

RSP, BASEPLATE RIM PLANER 40MM* DO NOT BUY
Encore Medical, L.P.
804-03-035
In Commercial Distribution

  • 00888912440998 ()


  • Bone-resection orthopaedic reamer, reusable

Millennium - 00190776200282

DELL ASTIGMATISM MARKER GILLS and
Avalign Technologies, Inc.
92-CM01302
In Commercial Distribution

  • 00190776200282 ()


  • Corneal marker, reusable

LRI/Toric Markers - 08175700109505

LRI Marker, 6mm & 8mm Chord Lengths, With Degree Gauge (Uses Dell/Gills Nomograms)
AURORA SURGICAL, LLC
AS3-500
In Commercial Distribution

  • 08175700109505 ()
AS3-500

  • Ophthalmic angular gauge, reusable

Integra® Miltex® - 10381780444763

Integra® Miltex® Luxating Elevator, 4-7/8", Curved Tip 5mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DELLUXC5
In Commercial Distribution

  • H834DELLUXC50 ()
  • 10381780444763 ()

  • 4-7/8"
  • Width: 5 Millimeter
DELLUXC5

  • Dental elevator, tooth/root

PillCam - 07290110360221

PillCam™ WS v9 Dell T5810, USA
Given Imaging, Inc.
FGS-0640
In Commercial Distribution

  • 07290110360221 ()


  • Video capsule endoscopy system application software

Brasseler USA - 00887919811824

K0360 ESR TRY BUY KIT 1P
Peter Brasseler Holdings, LLC
5026814U0
In Commercial Distribution

  • 00887919811824 ()


  • Rotary/reciprocating endodontic file/rasp, single-use

Integra® Miltex® - 10381780439547

Integra® Miltex® Luxating Elevator, Straight Tip 5mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DELLUXS5
In Commercial Distribution

  • H834DELLUXS50 ()
  • 10381780439547 ()
DELLUXS5

  • Dental elevator, tooth/root

Integra® Miltex® - 10381780439530

Integra® Miltex® Luxating Elevator, Straight Tip 4mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DELLUXS4
In Commercial Distribution

  • H834DELLUXS40 ()
  • 10381780439530 ()

  • 4-7/8"
DELLUXS4

  • Dental elevator, tooth/root
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