FDA.reportPublic FDA data

ColActive® Plus Powder

Primary DI
00825439017241
Brand
ColActive® Plus Powder
Company
Covalon Technologies Ltd
Model
80P0001
Device description
Collagen dressing
Published
2022-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00825439017258PackageGS110Not in Commercial Distribution
10825439017255PackageGS110Not in Commercial Distribution
00825439017241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439017258008254390172588254390172580825439017258
1082543901725510825439017255
00825439017241008254390172418254390172410825439017241

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
206936101
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00825439012062MediClear™ Scar 10x10900101090010102023-07-14
00825439012260MediClear™ Scar 4x4900040490004042023-07-14
00825439012291MediClear™ Scar 6x7900060790006072023-07-14
00825439012321MediClear™ Scar 6x30900063090006302023-07-14
00825439012789MediClear™ PreOp 70010122018-04-30
00825439012819MediClear PreOp70006302022-12-01
00825439012994MediClear PreOp70006252022-12-01
00825439016169MediClear™ PreOp70008302018-05-18
00825439012871MediClear™ PreOp70006072018-04-30
00825439010136IV Clear 4x4 with crosshairTWBD10112022-11-30
00825439010334SurgiClear 4x4TWBD10222022-12-01
00825439010464IV Clear 4x4TWBD10132022-11-30
00825439011188"ColActive® Plus 2""x2"""55502202022-11-30
00825439011218"ColActive® Plus 4""x4"""55504402022-11-30
00825439011249"ColActive® Plus 7""x7"""55507702022-11-30
00825439011270"ColActive® Plus Ag 2""x2"""55512202022-11-30
00825439011300"ColActive® Plus Ag 4""x4"""55514402022-11-30
00825439011331"ColActive® Plus Ag 7""x7"""55517702022-11-30
00825439013472ColActive® Transfer 4x455504412022-12-05
00825439017265ColActive® Plus Powder Ag81P00012022-11-30

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Primary DI, Brand, Company table
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