FDA.reportPublic FDA data

Nuvafoam

Primary DI
00699923012018
Brand
Nuvafoam
Company
Cpn Biosciences, LLC
Model
3012
Catalog number
3012
Device description
"Foam Dressing, 4"" x 4.25"""
Published
2023-09-22
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
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00699923012100PackageGS110Not in Commercial Distribution
00699923012506PackageGS112Not in Commercial Distribution
00699923012018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00699923012100006999230121006999230121000699923012100
00699923012506006999230125066999230125060699923012506
00699923012018006999230120186999230120180699923012018

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature

Regulatory Flags#

DUNS number
079896008
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
00699923103129Nuvawrap310331032023-10-03
00699923656106Nuvadhere365636562023-09-22
00699923103501Nuvawrap310331032023-10-03
00699923322506Nuvasorb (2"x2")332233222023-10-03
00699923342252Nuvasorb (4"x4") 334233422023-10-03
10618474000524Nuvagen Collagen Dressing100210022023-09-22
00699923012100Nuvafoam301230122023-09-22
00699923656502Nuvadhere365636562023-09-22

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Primary DI, Brand, Company table
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