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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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Speedlock - 00848657002981

Grasper, 5mm with spoon
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21
In Commercial Distribution

  • 00848657002981 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657000864

Babcock, 5mm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-01-R
In Commercial Distribution

  • 00848657000864 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657000741

Babcock 10mm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8514-97-R
In Commercial Distribution

  • 00848657000741 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Precise - 00848657016742

Babcock, 10mm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
P1545-R
In Commercial Distribution

  • 00848657016742 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

AED - 00848657015462

Resectoscope Sheath with Obturator
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
32-4221RR
In Commercial Distribution

  • 00848657015462 ()


  • Resectoscope

Innospire Elegance - 00383730004112

ELEGANCE WITH SSR (RUSSIA)
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730004112 ()
1103294

  • Benchtop nebulizer, non-heated

Natus® - 00382830056861

Pudenz Catheter with Stylet
NATUS MEDICAL INCORPORATED
NT8501228
In Commercial Distribution


  • Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NT8501228

  • Intracerebral infusion/drainage catheter, long-term

Natus - 00382830056335

RetCam Envision with FA
XLTEK
61-000300
In Commercial Distribution

  • 00382830056335 ()


  • Ophthalmic fundus camera

Calix Spinal Implant System - M697X00300151

Inserter Assembly, with Stop
Xtant Medical Holdings, Inc.
X003-0015
In Commercial Distribution

  • M697X00300150 ()
  • M697X00300151 ()


  • Polymeric spinal interbody fusion cage

Ceramco® 3 - D0013016050

With Powder Opaque Kit
Dentsply International Inc.
16 Shade Basic System
Not in Commercial Distribution

  • D0013016050 ()
301605

  • Dental appliance fabrication material, ceramic
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