Spirotome

Primary DI
05407005001059
Brand
Spirotome
Company
Bioncise
Model
SS0806
Catalog number
SS0806
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 stylet• A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula• A release elementThis presentation has an external diameter of 08G (5mm) and length of 60 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

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
05407005000052PackageGS15In Commercial Distribution
05407005001059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407005000052054070050000525407005000052
05407005001059054070050010595407005001059

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
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
05407005001233Spirotome BoneSS08BOSS08BO2018-08-31