ColActive Plus Powder Ag Wound Filler

GUDID 04052199578736

ColActive Plus Powder Ag Wound Filler

PAUL HARTMANN AG

Cavity-wound management dressing, antimicrobial
Primary Device ID04052199578736
NIH Device Record Key55f57e5e-ed35-4ab8-8904-28bd22852023
Commercial Distribution StatusIn Commercial Distribution
Brand NameColActive Plus Powder Ag Wound Filler
Version Model Number10160002
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104052199578729 [Primary]
GS104052199578736 [Package]
Contains: 04052199578729
Package: [1 Units]
In Commercial Distribution
GS104052199578743 [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 Date2021-09-06
Device Publish Date2021-08-27

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04052199571423 - Hydrofilm 15x20cm sterile P502023-05-25 Hydrofilm 15x20cm sterile P50
04052199571461 - Hydrofilm 20x30cm sterile P102023-05-25 Hydrofilm 20x30cm sterile P10
04052199571508 - Hydrofilm 10x15cm sterile P502023-05-25 Hydrofilm 10x15cm sterile P50
04052199571546 - Hydrofilm 10x12,5cm sterile P1002023-05-25 Hydrofilm 10x12,5cm sterile P100
04052199571577 - Hydrofilm 10x12,5cm sterile P102023-05-25 Hydrofilm 10x12,5cm sterile P10

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