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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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OneTouch SureSoft - 00353885006842

One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-141
In Commercial Distribution

  • 20353885006846 ()
  • 00353885006842 ()
  • 53885-141-10 ()
  • 80353885006824 ()

  • Needle Gauge: 18 Gauge


  • Manual blood lancing device, single-use

UTM-RT - 38053326009298

UTM-RT KIT Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens One Flexible Flocked Swab and One Regular Flocked Swab
COPAN ITALIA SPA
3C039N.HL
In Commercial Distribution

  • 58053326009292 ()
  • 38053326009298 ()
  • 18053326009294 ()
3C039N.HL

  • General specimen collection kit

Lucitone® FRS® - D0019048580

Contains one (1) Lucitone FRS 12 Pack Original Shade (904854) and one (1) Lucitone FRS 12 Pack Clear (904853)
Dentsply International Inc.
Starter Kit
Not in Commercial Distribution

  • D0019048580 ()
904858

  • Dental appliance fabrication material, thermoplastic

Spike Adapter - 10816203020632

One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps
ORIGEN BIOMEDICAL, INC.
40-S-V-SMM
Not in Commercial Distribution

  • 10816203020632 ()
  • 20816203020639 ()


  • Blood transfer set

LnK Spinal Fixation System - 08806189864158

1815-5262 L&K Biomed Side Click Connector, One by one L:25, W:8, D1:5.2,D2:6.2 1EA
L&K BIOMED CO. ,LTD.
1815-5262
In Commercial Distribution

  • 08806189864158 ()
1815-5262

  • Bone-screw internal spinal fixation system connector

HeadFrame Kit w/20 Short + 20 Long Head Screws - 00858086006306

Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 00858086006252 Headframe Kit
VARIAN MEDICAL SYSTEMS, INC.
P1006805005
In Commercial Distribution

  • 00858086006306 ()


  • Stereotactic radiosurgical invasive head frame

OBALON® - 00859810006227

OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
Reshape Lifesciences Inc.
9410-0001
Not in Commercial Distribution

  • 10859810006224 ()
  • 00859810006227 ()


  • Appetite-suppression gastric balloon deployment device/set
  • Appetite-suppression gastric balloon

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166511432

YF-02 Full Face Mask Pack, include one frame, one headgear and three cushions (Small, Medium, Large), for single-patient use.
Suzhou Yuyue Medical Technology Co., Ltd.
YF-02 (SML)
In Commercial Distribution

  • 26922166511436 ()
  • 06922166511432 ()


  • CPAP/BPAP face mask, reusable

LARGE UNI-CLIP® - 10381780041986

The sterilisation container is used in the transport and the sterilization of the LARGE UNI-CLIP® associated instruments and non sterile implants. It includes one base with reference 119992ND, one lid with reference 119991ND one cylinder with reference 119993ND, one tray with reference 119994ND, one insert with reference 119995ND and one base with reference 119996ND. The transport and sterilization containers are not intended to maintain sterility.
NEWDEAL
119990ND
Not in Commercial Distribution

  • M248119990ND1 ()
  • 10381780041986 ()


  • Device sterilization/disinfection container, reusable

642E Centrifuge, Exam One - 00810052860992

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-018-017-000
In Commercial Distribution

  • 00810052860992 ()
00-018-017-000

  • General-purpose centrifuge IVD
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