FDA.reportPublic FDA data

UriFree

Primary DI
58053326010960
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428981112
Device count
50
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
58053326007021FLOQSwabs®53380CS0153380CS012026-03-20
58053326011820BD FCT4453884453882026-01-26
08053326011771LBM CABroth4U161N4U161N2025-09-22
58053326011653CLASSIQSwab10494425001104944250012025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® 10494417001104944170012025-07-03
58053326009551Copan Universal Transport Medium (UTM-RT) System3C047N3C047N2025-05-28
18053326009867Copan Universal Transport Medium (UTM-RT) System3C057N3C057N2025-05-28
18053326010283Copan Universal Transport Medium (UTM-RT) System3C064N3C064N2025-05-28
08053326010446Copan Universal Transport Medium (UTM-RT) System3C075N3C075N2025-05-28
58053326011073Copan Universal Transport Medium (UTM-RT) System3C085N013C085N012025-05-28
58053326011189Copan Universal Transport Medium (UTM-RT) System3C088N013C085N012025-05-28
18053326010405Copan Universal Transport Medium (UTM-RT) System3C071N3C071N2025-05-28
58053326011714UriSponge™8U033S508U033S502025-03-12
58053326011684FLOQSwabs® 5U198S5U198S2024-12-18
58053326011592UTM®3C098N3C098N2024-11-13
58053326011608UTM® 3C099N01 3C099N01 2024-11-13
58053326011615UTM® 3C100N013C100N012024-11-13
58053326011509FLOQSwabs® NES4001NES40012024-07-02
58053326011523FLOQSwabs® 5000776005000776002024-07-02
28053326004524Sample Diluent Tube0C018S0C018S2024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B686600050ProteX with FlightLock TechnologyRSI Technology Group, LLCKDT2026-04-01
B686600061ProteX with FlightLock TechnologyRSI Technology Group, LLCKDT2026-04-01
04066916044077Tube with cap, 82x13mmSarstedt Aktiengesellschaft & Co.KGKDT2025-09-26
04038917310949Biosphere® screw cap, whiteSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917326698Biosphere® Screw Cap, greenSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917328289Biosphere® screw cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917369909Biosphere® Screw Cap, redSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411769Biosphere® screw cap, yellowSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411790Biosphere® Screw Cap, violetSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411820Biosphere® Screw Cap, blueSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411851Biosphere® Screw Cap, blackSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411882Biosphere® screw cap, neutralSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
G669CNBOX1CST0Crow's Nest Biopsy Catchment SystemCorramedical Inc.KDT2025-07-09
G669CNBOX4CST1Crow's Nest Biopsy Catchment SystemCorramedical Inc.KDT2025-07-09
20809160466947Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
0406691600597925 ml tube 90x 25Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-28
04066916018405urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
04038917923460Srew cap, pinkSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917923521Srew cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917994590SC MTube 0,5 ml Sarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917242578Tube 50ml, 114x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-16
04038917189705Tube 50ml, 115x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-07
04038917408578Tube 5ml, 75x13mmSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917994248Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917996570Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04066916005399Urine cup NFT 100ml temp. labSarstedt Aktiengesellschaft & Co.KGKDT2024-07-22
04038917410021Tube 39 x 13 Sarstedt Aktiengesellschaft & Co.KGKDT2024-05-22
10850054552041US Paramed Collection Oral Fluid KitQuest DiagnosticsKDT2024-05-01
0403891736996110ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
040389179925418,5 ml Urine Monovette Sarstedt Aktiengesellschaft & Co.KGKDT2024-04-26