FDA.reportPublic FDA data

"Nuvasorb (2""x2"")"

Primary DI
00699923322018
Brand
"Nuvasorb (2""x2"")"
Company
Cpn Biosciences, LLC
Model
3322
Catalog number
3322
Device description
"Surgical Sponges, 2""x2"""
Published
2023-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00699923322506PackageGS150Not in Commercial Distribution
00699923322018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00699923322506006999233225066999233225060699923322506
00699923322018006999233220186999233220180699923322018

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, non-antimicrobialA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

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
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
10618474000524Nuvagen Collagen Dressing100210022023-09-22
00699923012100Nuvafoam301230122023-09-22
00699923656502Nuvadhere365636562023-09-22

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