Spirotome Endo SS14EN

GUDID 05407005000212

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 ID05407005000212
NIH Device Record Key3763e6e5-db37-46c4-b87b-174d9d51113c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpirotome Endo
Version Model NumberSS14EN
Catalog NumberSS14EN
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
GS105407005000212 [Package]
Contains: 05407005001219
Package: Box [5 Units]
In Commercial Distribution
GS105407005001219 [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 Endo]

05407005000229The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000212The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000205The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
05407005000199The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use

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