ColActive Plus AG 4x4 300/cs

GUDID 00825439010105

ColActive Plus AG 4x4 300/cs

PAUL HARTMANN AG

Collagen wound matrix dressing
Primary Device ID00825439010105
NIH Device Record Keya8ebecfb-860a-4e6a-a152-e40ca4b71f53
Commercial Distribution StatusIn Commercial Distribution
Brand NameColActive Plus AG 4x4 300/cs
Version Model Number10340000
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
GS100825439010105 [Primary]
GS100825439010235 [Package]
Package: [10 Units]
In Commercial Distribution
GS110825439010249 [Package]
Contains: 00825439010235
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

Devices Manufactured by PAUL HARTMANN AG

20612553013440 - AC TAPE PLUS 2X5 72/CS2024-01-24 AC TAPE PLUS 2X5 72/CS
04052199571331 - Hydrofilm 6x7cm sterile New P1002023-05-25 Hydrofilm 6x7cm sterile New P100
04052199571393 - Hydrofilm 6x7cm sterile P102023-05-25 Hydrofilm 6x7cm sterile P10
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.