8009S

GUDID 03596010266262

SVCE REPL VLS 5MM X 0 DEG

Smith & Nephew, Inc.

Rigid optical laparoscope

• Primary Device ID: 03596010266262
• NIH Device Record Key: d587a6af-3d4b-4b97-b283-c396c35cefbc
• Commercial Distribution Discontinuation: 2017-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 8009S
• Catalog Number: 8009S
• 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	03596010266262 [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

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

Moist Heat or Steam Sterilization

[03596010266262]

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

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• 00885556901984 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP
• 00885556901991 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 32MM CORTEX SCREW BLUNT TIP
• 00885556902004 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 34MM CORTEX SCREW BLUNT TIP
• 00885556902011 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 36MM CORTEX SCREW BLUNT TIP
• 00885556902028 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 38MM CORTEX SCREW BLUNT TIP