NuStat Flex XR

GUDID 00850392006506

BEEKEN BIOMEDICAL LLC

Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated, sterile Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated
Primary Device ID00850392006506
NIH Device Record Key90ddc141-a867-4137-a751-d71fce17b327
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuStat Flex XR
Version Model NumberXR-3000097331
Company DUNS028807882
Company NameBEEKEN BIOMEDICAL LLC
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850392006506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-18
Device Publish Date2021-01-08

On-Brand Devices [NuStat Flex XR]

00850392006537XR-3000097317
00850392006520XR-3000097333
00850392006513XR-3000097320
00850392006506XR-3000097331
008503920062783000097333
008503920062613000097331
008503920062543000097320
008503920062473000097319
008503920062303000097318
008503920062233000097317
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