LENS 4K 72205230

GUDID 00885556731185

KIT SWEDISH LENS 4K CCU WIFI VERSION

Smith & Nephew, Inc.

Camera control unit

• Primary Device ID: 00885556731185
• NIH Device Record Key: bd6ccc39-a8f9-4367-9fa5-00eb42ded3fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LENS 4K
• Version Model Number: 72205230
• Catalog Number: 72205230
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556731185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191177

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-27
• Device Publish Date: 2019-09-19

On-Brand Devices [LENS 4K]

• 00885556765807: KIT OUS LENS 4K A/C CAMERA HEAD
• 00885556730959: KIT KOREAN LENS 4K CCU NON WIFI
• 00885556730942: KIT DUTCH LENS 4K CCU NON WIFI
• 00885556730935: KIT NORWEGIAN LENS 4K CCU NON WIFI
• 00885556730911: KIT PORTUGUESE LENS 4K CCU NON WIFI
• 00885556730904: KIT SWEDISH LENS 4K CCU NON WIFI
• 00885556730881: KIT FRENCH LENS 4K CCU NON WIFI
• 00885556730874: KIT SPANISH LENS 4K CCU NON WIFI
• 00885556730867: KIT GERMAN LENS 4K CCU NON WIFI
• 00885556730850: KIT US LENS 4K CCU NON WIFI
• 00885556765791: KIT US LENS 4K A/C CAMERA HEAD
• 00885556731260: KIT UK LENS 4K WIFI VERSION
• 00885556731246: KIT INTERNATIONAL LENS 4K CCU WIFI VERSION
• 00885556731239: KIT KOREAN LENS 4K CCU WIFI VERSION
• 00885556731222: KIT DUTCH LENS 4K CCU WIFI VERSION
• 00885556731215: KIT NORWEGIAN LENS 4K CCU WIFI VERSION
• 00885556731208: KIT DANISH LENS 4K CCU WIFI VERSION
• 00885556731192: KIT PORTUGUESE LENS 4K CCU WIFI VERSION
• 00885556731185: KIT SWEDISH LENS 4K CCU WIFI VERSION
• 00885556731178: KIT ITALIAN LENS 4K CCU WIFI VERSION
• 00885556731161: KIT FRENCH LENS 4K CCU WIFI VERSION
• 00885556731154: KIT SPANISH LENS 4K CCU WIFI VERSION
• 00885556731147: KIT GERMAN LENS 4K CCU WIFI VERSION
• 00885556731130: KIT US LENS 4K CCU WIFI VERSION
• 00885556730980: KIT UK LENS 4K CCU NON WIFI
• 00885556730966: KIT INTERNATIONAL LENS 4K CCU NON WIFI
• 00885556730706: LENS 4K CCU NON WIFI VERSION
• 00885556730928: KIT DANISH LENS 4K CCU NON WIFI
• 00885556730898: KIT ITALIAN LENS 4K CCU NON WIFI
• 00885556757031: SERVICE REPLACEMENT LENS 4K CCU WIFI
• 00885556757024: REFURBISHED 4K A/C CAMERA HEAD
• 00885556757017: SERVICE REPLACEMENT 4K A/C CAMERA HEAD