FDA.reportPublic FDA data

Nuvagen Collagen Dressing

Primary DI
10618474000524
Brand
Nuvagen Collagen Dressing
Company
Cpn Biosciences, LLC
Model
1002
Catalog number
1002
Device description
Sterile, disposable, single-use collagen wound dressing (2"x2"). It is a hydrocolloid and hydrophilic dressing composed of fibrous type I bovine collagen.
Published
2023-09-22
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
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122325000SKINTEMP IIHuman Biosciences, Inc.2012-10-26KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10618474000524PackageGS15In Commercial Distribution
00618474000527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061847400052410618474000524
00618474000527006184740005276184740005270618474000527

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079896008
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618474000527Nuvagen Collagen Dressing100210022023-09-22
00618474000510Nuvagen Collagen Powder200220022023-09-22
00699923322018"Nuvasorb (2""x2"")"332233222023-10-03
00699923342016"Nuvasorb (4""x4"") "334233422023-10-03
00699923012018Nuvafoam301230122023-09-22
00699923103129Nuvawrap310331032023-10-03
00699923656106Nuvadhere365636562023-09-22
00699923103501Nuvawrap310331032023-10-03
00699923322506Nuvasorb (2"x2")332233222023-10-03
00699923342252Nuvasorb (4"x4") 334233422023-10-03
00699923012100Nuvafoam301230122023-09-22
00699923656502Nuvadhere365636562023-09-22

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Primary DI, Brand, Company table
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