FDA.reportPublic FDA data

Nuvasorb (4"x4")

Primary DI
00699923342252
Brand
Nuvasorb (4"x4")
Company
Cpn Biosciences, LLC
Model
3342
Catalog number
3342
Device description
Surgical sponge, 4"x4"
Published
2023-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00699923342252PackageGS125In Commercial Distribution
00699923342504PackageGS124In Commercial Distribution
00699923342016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00699923342252006999233422526999233422520699923342252
00699923342504006999233425046999233425040699923342504
00699923342016006999233420166999233420160699923342016

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze padA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079896008
Device count
1
DM exempt
false
Premarket exempt
true
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
10618474000524Nuvagen Collagen Dressing100210022023-09-22
00699923012100Nuvafoam301230122023-09-22
00699923656502Nuvadhere365636562023-09-22

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