Flexision

GUDID 10886874115951

Biopsy Needle, 23G

INTUITIVE SURGICAL, INC.

Body aspiration needle, single-use
Primary Device ID10886874115951
NIH Device Record Key5ba83bc7-fece-4bf0-80ec-aaa4180e12e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexision
Version Model Number490102
Company DUNS938647021
Company NameINTUITIVE SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886874115954 [Primary]
GS110886874115951 [Package]
Contains: 00886874115954
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (flexible or rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-02
Device Publish Date2019-03-21

On-Brand Devices [Flexision]

10886874115975Biopsy Needle, 19G
10886874115968Biopsy Needle, 21G
10886874115951Biopsy Needle, 23G

Trademark Results [Flexision]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEXISION
FLEXISION
88408980 not registered Live/Pending
Intuitive Surgical Operations, Inc.
2019-04-30

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