COLACTIVE PLUS 7x7 10/BX

GUDID 00825439010365

COLACTIVE PLUS 7x7 10/BX

PAUL HARTMANN AG

Collagen wound matrix dressing
Primary Device ID00825439010365
NIH Device Record Keya52c01a6-cb32-4769-9518-f6cea3edbbc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOLACTIVE PLUS 7x7 10/BX
Version Model Number10350000
Company DUNS315768788
Company NamePAUL HARTMANN AG
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 Datetrue
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
GS100825439010358 [Primary]
GS100825439010365 [Package]
Contains: 00825439010358
Package: [10 Units]
In Commercial Distribution
GS110825439010362 [Package]
Package: [10 Units]
In Commercial Distribution

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 Date2020-09-09
Device Publish Date2020-09-01

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