FDA.reportPublic FDA data

UriFree

Primary DI
38053326010966
Brand
UriFree
Company
COPAN ITALIA SPA
Model
2E127S50.A
Catalog number
2E127S50.A
Device description
Sterile container for urine transfer
Published
2022-12-07
Public version status
New
Distribution status
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
KDTContainer, Specimen Mailer And Storage, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58053326010960PackageGS16In Commercial Distribution
38053326010966PrimaryGS10
08053326010965Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5805332601096058053326010960
3805332601096638053326010966
08053326010965080533260109658053326010965

GMDN Terms#

Term, Definition table
TermDefinition
Specimen transfer scooping tool IVDA hand-held manual instrument intended to be used to scoop a clinical specimen or microbial isolate for transfer from a primary vessel to a secondary container (e.g., from a specimen collection receptacle to a reagent tube, or from a culture medium to a general laboratory test tube) for subsequent in vitro diagnostic analysis and/or other investigation. It is typically a slender device with a loop, rake, or ball at the distal end used to scoop and transfer the clinical specimen or microbial isolate. This is a single-use device.

Regulatory Flags#

DUNS number
428981112
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
04038917310932Biosphere® screw cap, whiteSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917326681Biosphere® Screw Cap, greenSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917328272Biosphere® screw cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917369893Biosphere® Screw Cap, redSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411752Biosphere® screw cap, yellowSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411783Biosphere® Screw Cap, violetSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411813Biosphere® Screw Cap, blueSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411844Biosphere® Screw Cap, blackSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411875Biosphere® screw cap, neutralSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
0406691600599325 ml tube 90x 25Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-28
04066916018412urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
04038917923446Srew cap, pinkSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917923507Srew cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917994576SC MTube 0,5 mlSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917242561Tube 50ml, 114x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-16
04038917113571Tube 50ml, 115x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-07
04038917408561Tube 5ml, 75x13mmSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917994224Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917996556Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917432146Tube 39 x 13Sarstedt Aktiengesellschaft & Co.KGKDT2024-05-22
0403891736995410ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
04038917989657Screw cap.134GD BRAUN BIO.VD VZ50Sarstedt Aktiengesellschaft & Co.KGKDT2024-02-20
04038917112970Tube 15ml, 120x17mm, PSSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917113007Tube 15ml, 120x17mm, PSSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917565103Tube 15ml, 120x17mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917112529tube with screw cap 7ml, 82x13mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-07-22
04038917238649Tube 25ml 90x25PP+ CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-19