Spirotome SS0810

GUDID 05407005000038

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 tissu

Bioncise

Soft-tissue biopsy needle, single-use
Primary Device ID05407005000038
NIH Device Record Key7b6d0bf5-403a-4bca-a99b-896398e2dc5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpirotome
Version Model NumberSS0810
Catalog NumberSS0810
Company DUNS371402316
Company NameBioncise
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105407005000038 [Package]
Contains: 05407005001035
Package: Box [5 Units]
In Commercial Distribution
GS105407005001035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-31

On-Brand Devices [Spirotome]

05407005000168The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000151The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000144The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000137The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000120The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000113The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000106The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000090The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000083The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000076The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005001066The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000052The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000045The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000038The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005001028The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000014The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use

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