FDA.reportPublic FDA data

COLACTIVE PLUS AG 7x7 10/BX

Primary DI
00825439010198
Brand
COLACTIVE PLUS AG 7x7 10/BX
Company
PAUL HARTMANN AG
Model
10320000
Device description
COLACTIVE PLUS AG 7x7 10/BX
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060804000COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSINGCovalon Technologies, Ltd.2006-04-18FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825439010204PackageGS110In Commercial Distribution
10825439010201PackageGS110In Commercial Distribution
00825439010198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439010204008254390102048254390102040825439010204
1082543901020110825439010201
00825439010198008254390101988254390101980825439010198

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315768788
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052199810157Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810171Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810195Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09
04052199810164Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810188Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810201Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09
04052199777399Zetuvit Plus413600 Zetuvit Plus Shapes Oval4136002026-01-20
04052199777405Zetuvit Plus413601 Zetuvit Plus Shapes Heart Multisite P10 C64136012026-01-20
04052199777429Zetuvit Plus413602 Zetuvit Plus Shapes Multisite P10 C64136022026-01-20
04052199777382Zetuvit Plus413600 Zetuvit Plus Shapes Oval4136002026-01-20
04052199777412Zetuvit Plus413601 Zetuvit Plus Shapes Heart Multisite P10 C64136012026-01-20
04052199777436Zetuvit Plus413602 Zetuvit Plus Shapes Multisite P10 C64136022026-01-20
04052199708928Zetuvit Plus413729 Zetuvit Plus 6 x 6 cm P104137292024-12-10
04052199708942Zetuvit Plus413739 Zetuvit Plus 20 x 60 cm P104137392024-12-10
04052199708935Zetuvit Plus413729 Zetuvit Plus 6 x 6 cm P104137292024-12-10
04052199708959Zetuvit Plus413739 Zetuvit Plus 20 x 60 cm P104137392024-12-10
04052199732435Atrauman Ag499607 Atrauman Ag USA st 10x10cm, P104996072025-03-19
04052199732466Atrauman Ag499608 Atrauman Ag USA st 10x20cm, P104996082025-03-19
04052199732404Atrauman Ag499606 Atrauman Ag USA st 5x5cm, P10499606 2025-03-19
04049500030915Peha-Haft 2.5cmx4m P8 C12932452 Peha-Haft 2.5cmx4m P8 C129324522020-09-01

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