8018S

GUDID 03596010267306

SVCE REPL 10MM X 30 DEG VLS

Smith & Nephew, Inc.

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.

• 00885556892954 - TRIGEN MAX: 2025-05-20 TRIGEN MAX TIBIA NAIL 9MM X 29CM LEFT
• 00885556894552 - NA: 2025-05-20 TRIGEN MAX 5.0MM LOCKING SCREW - 77.5MM
• 00885556896662 - NA: 2025-05-20 TRIGEN MAX 5.0MM LAG SCREW - 77.5MM
• 00885556892596 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 34CM LEFT
• 00885556892619 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 36CM LEFT
• 00885556892626 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 37CM LEFT
• 00885556892633 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 38CM LEFT
• 00885556892640 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 39CM LEFT