MicroTek DVT Sleeve

GUDID 10861317020306

MicroTek Medical Venodyne

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed
Primary Device ID10861317020306
NIH Device Record Keye926db46-8bcc-4f1e-b389-0cc1fe29e69e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroTek DVT Sleeve
Version Model NumberRM-V3012
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861317020309 [Primary]
GS110861317020306 [Package]
Contains: 00861317020309
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [MicroTek DVT Sleeve]

10861317020320MicroTek Medical Venodyne Bariatric
10861317020313MicroTek Medical Venodyne Lg
10861317020306MicroTek Medical Venodyne
10816317020320MicroTek Medical Venodyne Bariatric
10816317020313MicroTek Medical Venodyne Lg
10816317020306MicroTek Medical Venodyne

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