8018S

GUDID 03596010267306

SVCE REPL 10MM X 30 DEG VLS

Smith & Nephew, Inc.

Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope

• Primary Device ID: 03596010267306
• NIH Device Record Key: 8efb7eb2-fb8c-41ed-bb43-3db7326ca082
• Commercial Distribution Discontinuation: 2017-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 8018S
• Catalog Number: 8018S
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010267306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980604

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

[03596010267306]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-09-28

Devices Manufactured by Smith & Nephew, Inc.

• 00885556817667 - TULA: 2024-05-07 TULA KIT- UNILATERAL (NST007068)
• 00885556890745 - Q-FIX: 2024-05-06 Q-FIX ULTRA
• 00885556890752 - ULTRABRACE: 2024-05-06 ULTRABRACE KIT
• 00885556890769 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI PK 3.5MM
• 00885556890790 - Q-FIX: 2024-05-06 2.9MM CANNULATED DRILL FOR Q-FIX ULTRA & 1.25MM DRILL PIN
• 00885556890912 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI DRILL 3.5MM
• 00885556901335 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI DRILL 3.7MM
• 20885556817692 - TULA: 2024-05-06 TULA EARPLUG 10-PACK- SIZE 2 (NST007071)