FDA.reportPublic FDA data

UNIVERSAL DUO

Primary DI
08055002909822
Brand
UNIVERSAL DUO
Company
MEDAX SRL UNIPERSONALE
Model
UD18250-0P
Device description
Biopsy needle 18G x 250 mm
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181803000Medax Biopsy Systems IIIMedax Srl Unipersonale2018-10-18KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055002909829PackageGS110In Commercial Distribution
08055002909822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805500290982918055002909829
08055002909822080550029098228055002909822

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Regulatory Flags#

DUNS number
440211428
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055002900003UNIVERSALUN18100-002018-04-10
08055002904247FNA CHIBACH18160-012019-10-02
08055002904308FNA CHIBACH18200-012019-10-02
08055002904513FNA CHIBACH20160-012019-10-02
08055002904896FNA CHIBACH22100-012019-08-09
08055002904971FNA CHIBACH22160-012019-08-09
08055002905039FNA CHIBACH22200-012019-07-18
08055002909662UNIVERSAL DUOUD14100-0P2018-04-10
08055002909686UNIVERSAL DUOUD14160-0P2018-10-29
08055002909761UNIVERSAL DUOUD18100-0P2018-04-10
08055002909808UNIVERSAL DUO UD18160-0P2018-04-10
08055002909815UNIVERSAL DUOUD18200-0P2018-04-10
08055002909839UNIVERSAL DUOUD18300-0P2018-04-10
08056515880011UNIVERSALUN18160-002018-04-10
08056515880028UNIVERSALUN18200-002018-04-10
08056515880035UNIVERSALUN18250-002018-04-10
08056515880042UNIVERSAL UN18300-002018-04-10
08056515880257UNIVERSAL PLUSUP18100-002018-04-10
08056515880288UNIVERSAL PLUSUP18160-002018-04-10
08056515880295UNIVERSAL PLUSUP18200-002018-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033860001926BIOPSYBELL SRLBIOPSYBELL SRLKNW2023-10-23
08033860000141BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000189BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000240BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000264BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000448BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000462BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000547BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000585BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860001087BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860002664BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860005290BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860005597BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860010393BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000080BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000103BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000127BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000165BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000523BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860001063BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860003142BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860004255BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860004453BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860009311BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860001681BIOPSYBELL SRLBIOPSYBELL SRLKNW2023-08-31
08033860002909BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860002961BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003203BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003401BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003777BiopsybellBIOPSYBELL SRLKNW2023-08-31