FDA.reportPublic FDA data

Spirotome Spine

Primary DI
05407005001257
Brand
Spirotome Spine
Company
Bioncise
Model
SS08SP
Catalog number
SS08SP
Device description
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver.The Spirotome Biopsy Needle Set contains:• A two-part introducer needle that consists of a cutting cannula and a trocar• A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula- Injection needle• A release elementThis presentation has an external diameter of 8G (5 mm) and length of 150 mm.
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K080095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080095000CORAMATE/SPIROTOME SYSTEMMedinvents2008-04-11KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407005000250PackageGS15In Commercial Distribution
05407005001257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407005000250054070050002505407005000250
05407005001257054070050012575407005001257

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
371402316
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05407005001011SpirotomeSS0820SS08202018-08-31
05407005001035SpirotomeSS0810SS08102018-08-31
05407005001042SpirotomeSS0808SS08082018-08-31
05407005001059SpirotomeSS0806SS08062018-08-31
05407005001073SpirotomeSS1015SS10152018-08-31
05407005001080SpirotomeSS1010SS10102018-08-31
05407005001097SpirotomeSS1008SS10082018-08-31
05407005001103SpirotomeSS1006SS10062018-08-31
05407005001110SpirotomeSS1415SS14152018-08-31
05407005001127SpirotomeSS1410SS14102018-08-31
05407005001134SpirotomeSS1408SS14082018-08-31
05407005001141SpirotomeSS1406SS14062018-08-31
05407005001158SpirotomeSS08MRSS08MR2018-08-31
05407005001165SpirotomeSS10MRSSA10MR2018-08-31
05407005001172Spirotome CervicoreSS10CESS10CE2018-08-31
05407005001189Spirotome CervicoreSS08CESS08CC2018-08-31
05407005001196Spirotome EndoSS08ENSS08EN2018-08-31
05407005001202Spirotome EndoSS10ENSS10EN2018-08-31
05407005001219Spirotome EndoSS14ENSS14EN2018-08-31
05407005001226Spirotome EndoSS14EN1SS14EN12018-08-31

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