RegenLab USA

GUDID 00850033131079

Regenlab USA LLC

Blood collection set, noninvasive
Primary Device ID00850033131079
NIH Device Record Key95ba9be8-109b-4335-9689-4ca0636a5c47
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegenLab USA
Version Model NumberRK-WG-2
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033131079 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

Radiation Sterilization


[00850033131079]

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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