Reprocessed Venaflow Calf Cuff, Large, 1 Pair

GUDID B39030121

SURETEK MEDICAL

Single-chamber venous compression system garment, reprocessed
Primary Device IDB39030121
NIH Device Record Keye5935cb1-9f1b-48ea-adf0-e0942784a71a
Commercial Distribution Discontinuation2017-08-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameReprocessed Venaflow Calf Cuff, Large, 1 Pair
Version Model Number3012
Company DUNS785616934
Company NameSURETEK MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB39030121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-09
Device Publish Date2016-09-12

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