RegenLab USA

GUDID 00850033131086

Regenlab USA LLC

Blood collection set, noninvasive
Primary Device ID00850033131086
NIH Device Record Key521a426e-f32c-49cb-97d0-6290e664cdf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegenLab USA
Version Model NumberR-ET
Company DUNS087434117
Company NameRegenlab USA LLC
Device Count1
DM Exemptfalse
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033131086 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


[00850033131086]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-08
Device Publish Date2023-04-28

On-Brand Devices [RegenLab USA]

00850033131086R-ET
00850033131079RK-WG-2
00850033131062RK-THT-3-20-U
00850033131055RK-THT-3-U
00850033131048RK-BCT-3-20-U
00850033131031RK-BCT-3-U
00850033131109RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10

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