CRYOcheck™ Factor II Deficient Plasma

GUDID 00843876000220

Precision Biologic Inc

Multiple coagulation factor IVD, reagent
Primary Device ID00843876000220
NIH Device Record Keyb79a3014-85f5-47f5-99b5-9c0a45613d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRYOcheck™ Factor II Deficient Plasma
Version Model NumberFDP02-15
Company DUNS244713368
Company NamePrecision Biologic Inc
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100843876000220 [Primary]
GS100843876010229 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GJTPlasma, Coagulation Factor Deficient

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 Date2016-09-23

On-Brand Devices [CRYOcheck™ Factor II Deficient Plasma]

00843876000220FDP02-15
00843876000213FDP02-10

Trademark Results [CRYOcheck]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRYOCHECK
CRYOCHECK
77260682 3656409 Live/Registered
PRECISION BIOLOGIC INC.
2007-08-21

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