Flexision

GUDID 10886874115951

Biopsy Needle, 23G

INTUITIVE SURGICAL, INC.

Body aspiration needle, single-use Body aspiration needle, single-use Body aspiration needle, single-use

• Primary Device ID: 10886874115951
• NIH Device Record Key: 5ba83bc7-fece-4bf0-80ec-aaa4180e12e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexision
• Version Model Number: 490102
• Company DUNS: 938647021
• Company Name: INTUITIVE SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874115954 [Primary]
GS1	10886874115951 [Package]; Contains: 00886874115954; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182188

FDA Product Code

• EOQ: Bronchoscope (flexible or rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-02
• Device Publish Date: 2019-03-21

On-Brand Devices [Flexision]

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