ADI-25-05 ADIPREP Procedure Pack

GUDID 35020583514356

ADI-25-05 AdiPrep Procedure Pack

TERUMO BCT, INC.

Liposuction system
Primary Device ID35020583514356
NIH Device Record Key6720fc64-5ef0-4f8b-afb0-d3ee2fe9c0fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameADI-25-05 ADIPREP Procedure Pack
Version Model Number51435
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com
Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS135020583514356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUUSystem, suction, lipoplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-23
Device Publish Date2016-09-15

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