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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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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
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® 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
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
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
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
No Description
MEDOC LTD.
OBRU
In Commercial Distribution

  • 07290103039073 ()
DT 00012

  • Pressure algometer/aesthesiometer, electronic
No Description
I3 IMPLANT LLC
I3063080
In Commercial Distribution

  • 00810027861030 ()


  • Dental prosthesis/implant abutment screw analog, reusable
No Description
I3 IMPLANT LLC
I3063070
In Commercial Distribution

  • 00810027861023 ()


  • Dental prosthesis/implant abutment screw analog, reusable
No Description
I3 IMPLANT LLC
I3063060
In Commercial Distribution

  • 00810027861016 ()


  • Dental prosthesis/implant abutment screw analog, reusable
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