FDA.reportPublic FDA data

COLACTIVE PLUS 7x7 10/BX

Primary DI
20612553024293
Brand
COLACTIVE PLUS 7x7 10/BX
Company
HARTMANN USA, INC.
Model
10350000
Device description
COLACTIVE PLUS 7x7 10/BX
Published
2020-09-01
Public version status
Update
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
10612553024296PackageGS110In Commercial Distribution
20612553024293PackageGS110In Commercial Distribution
30612553024290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061255302429610612553024296
2061255302429320612553024293
3061255302429030612553024290

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
010137511
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
30612553024290COLACTIVE PLUS 7x7 10/BX103500002020-09-01
04052199578729ColActive Plus Powder Ag Wound Filler101600022021-08-27
04052199578750ColActive Plus Powder Wound Filler101600012021-08-27
30612553024276ColActive Plus 2x2101600002020-09-01
30612553024283ColActive Plus 4x4101800002020-09-01
30612553024306ColActive Plus AG 2x2 600/cs103300002020-09-01
30612553024313ColActive Plus AG 4x4 300/cs103400002020-09-01
30612553024320COLACTIVE PLUS AG 7x7 10/BX103200002020-09-01
10612553018073Sorbalgon Ag st 2g/30cm P59996092020-09-01
10612553018080Sorbalgon Ag st 15x15cm P59996102020-09-01
10612553018103Sorbalgon Ag st 5x5cm P109996122020-09-01
10612553023480PROXIMEL AG SILICONE DRESSING 3x3 10/BX151000002020-09-01
10612553023497PROXIMEL AG SILICONE DRESSING 4x4 10/BX152000002020-09-01
10612553023503PROXIMEL AG SILICONE DRESSING 6x6 5/BX153000002020-09-01
10612553023510PROXIMEL AG SILICONE DRESSING 4x12 5/BX154000002020-09-01
10612553023527PROXIMEL AG DRESSING SM SACRAL 5/BX155000002020-09-01
10612553018097Sorbalgon Ag st 10x10cm P109996112020-09-01
00612553000002CollaSorb 1g Powder9060039060032024-03-20
10612553015409STERILUX GZ SPONGE ST 2X2 8PLY 3000/CS568800002020-09-01
10612553015430STERILUX GZ SPONGE ST 4X4 12PLY 1200/CS569100002020-09-01

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