ColActive Plus AG 4x4 300/cs

GUDID 30612553024313

ColActive Plus AG 4x4 300/cs

HARTMANN USA, INC.

Collagen wound matrix dressing
Primary Device ID30612553024313
NIH Device Record Keya8ebecfb-860a-4e6a-a152-e40ca4b71f53
Commercial Distribution StatusIn Commercial Distribution
Brand NameColActive Plus AG 4x4 300/cs
Version Model Number10340000
Company DUNS010137511
Company NameHARTMANN USA, INC.
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
GS110612553024319 [Package]
Contains: 20612553024316
Package: CS [10 Units]
In Commercial Distribution
GS120612553024316 [Package]
Package: FBX [10 Units]
In Commercial Distribution
GS130612553024313 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-05-14
Device Publish Date2020-09-01

Devices Manufactured by HARTMANN USA, INC.

30612553024276 - ColActive Plus 2x22024-05-14 ColActive Plus 2x2
30612553024283 - ColActive Plus 4x42024-05-14 ColActive Plus 4x4
20612553024293 - COLACTIVE PLUS 7x7 10/BX2024-05-14 COLACTIVE PLUS 7x7 10/BX
30612553024306 - ColActive Plus AG 2x2 600/cs2024-05-14 ColActive Plus AG 2x2 600/cs
30612553024313 - ColActive Plus AG 4x4 300/cs2024-05-14ColActive Plus AG 4x4 300/cs
30612553024313 - ColActive Plus AG 4x4 300/cs2024-05-14 ColActive Plus AG 4x4 300/cs
30612553024320 - COLACTIVE PLUS AG 7x7 10/BX2024-05-14 COLACTIVE PLUS AG 7x7 10/BX
00612553000019 - CollaSorb 1g Powder2024-03-28 CollaSorb Powder Collagen Wound Filler
10612553024395 - AC-TAPE PLUS2024-01-24 AC-TAPE PLUS 3X5 48/CS

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