FDA.reportPublic FDA data

UriSponge™

Primary DI
58053326011714
Brand
UriSponge™
Company
COPAN ITALIA SPA
Model
8U033S50
Catalog number
8U033S50
Device description
UriSponge™ - Urine Collection, Transport, and Preservation System 100mm lenght x 16mm diameter
Published
2025-03-12
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
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232565000UriSponge™Copan Italia Spa2024-10-11JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58053326011714PackageGS16In Commercial Distribution
38053326011710PrimaryGS10
08053326011719Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5805332601171458053326011714
3805332601171038053326011710
08053326011719080533260117198053326011719

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated urine specimen container IVD, preservativeA covered receptacle containing one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, preservation, and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. It may include a disposable pipette to transfer the urine specimen into a secondary container (not included). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428981112
Device count
50
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
38053326007027FLOQSwabs®53380CS0153380CS012026-03-20
58053326007021FLOQSwabs®53380CS0153380CS012026-03-20
38053326011826BD FCT4453884453882026-01-26
58053326011820BD FCT4453884453882026-01-26
38053326011598UTM®3C098N3C098N2024-11-13
38053326011604UTM® 3C099N01 3C099N01 2024-11-13
38053326011611UTM® 3C100N013C100N012024-11-13
38053326011796FLOQSwabs®5U200S01.BD5U200S01.BD2025-10-01
38053326008420UTM® 3C042N3C042N2022-12-13
38053326011772LBM CABroth4U161N4U161N2025-09-22
08053326011771LBM CABroth4U161N4U161N2025-09-22
58053326011653CLASSIQSwab10494425001104944250012025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® 10494417001104944170012025-07-03
38053326011710UriSponge™8U033S508U033S502025-03-12
38053326009557Copan Universal Transport Medium (UTM-RT) System3C047N3C047N2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) System3C057N3C057N2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) System3C064N3C064N2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) System3C075N3C075N2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) System3C085N013C085N012025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) System3C088N013C085N012025-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973471962171BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962188BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962195BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962201BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962218BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962225BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962232BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962249BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962256BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962263BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
00810164510815Atida Viral Transport Medium (Non-inactivated Type)ACESO LABORATORIES INC.JSM2026-03-23
38053326011826BD FCTCOPAN ITALIA SPAJSM2026-01-26
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011710UriSponge™COPAN ITALIA SPAJSM2025-03-12
38053326011598UTM®COPAN ITALIA SPAJSM2024-11-13
38053326011604UTM® COPAN ITALIA SPAJSM2024-11-13
38053326011611UTM® COPAN ITALIA SPAJSM2024-11-13
00816576026067TransPROHARDY DIAGNOSTICSJSM2024-10-08
16977644780029BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780036BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780043BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780012BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-12
16973471969941BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23
16973471969996BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23