LENS 72204354S

GUDID 00885556632000

SERVICE REPLACEMENT LENS INTEGRATED SYSTEM WIFI VERSION

Smith & Nephew, Inc.

Endoscopic video imaging system

• Primary Device ID: 00885556632000
• NIH Device Record Key: 26e360b7-4277-43e5-9e77-c85818c1bfad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LENS
• Version Model Number: 72204354S
• Catalog Number: 72204354S
• Company DUNS: 109903521
• Company Name: Smith & Nephew, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556632000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153606

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-15

On-Brand Devices [LENS]

• 00885556632048: SERVICE REPLACEMENT COUPLER HD 17.2MM AUTOCLAVABLE
• 00885556632024: SERVICE REPLACEMENT LENS INTEGRATED SYSTEM NON-WIFI VERSION
• 00885556632000: SERVICE REPLACEMENT LENS INTEGRATED SYSTEM WIFI VERSION
• 00885556631980: SERVICE REPLACEMENT CAMERA HEAD LENS INTEGRATED SYSTEM
• 00885556629833: CAMERA HEAD LENS INTEGRATED SYSTEM
• 00885556624906: KIT UK LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618158: KIT INTERNATIONAL LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618141: KIT KOREAN LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618127: KIT DUTCH LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618110: KIT NORWEGIAN LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618103: KIT DANISH LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618097: KIT PORTUGUESE LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618080: KIT SWEDISH LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618073: KIT ITALIAN LENS INTEGRATED SYSTEM NON-WIFI
• 00885556618066: KIT FRENCH LENS INTEG SYSTEM NON-WIFI
• 00885556618059: KIT SPANISH LENS INTEG SYSTEM NON-WIFI
• 00885556618042: KIT GERMAN LENS INTEG SYSTEM NON-WIFI
• 00885556618035: KIT US LENS INTEGRATED SYSTEM NON-WIFI
• 00885556617908: LENS INTEGRATED SYSTEM NON-WIFI VERSION
• 00885556617878: LENS INTEGRATED SYSTEM WIFI VERSION
• 00885556616727: COUPLER HD 17.2MM AUTOCLAVABLE