INTERCEPTRE 7208301

GUDID 03596010380937

HANDLE RATCHET ASSY INTERCEP

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 03596010380937
• NIH Device Record Key: 77d86542-e843-472e-b3b6-ed5591b40d1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERCEPTRE
• Version Model Number: 7208301
• Catalog Number: 7208301
• 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: 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010380937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970151

FDA Product Code

• HET: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Sterilization

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

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

[03596010380937]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [INTERCEPTRE]

• 00885556609422: DEMO HANDLE RATCHET ASSY INTERCEP
• 03596010380944: INTERCEPTRE E/S HANDLE
• 03596010380920: SCSRS HOOK INTRCPTR
• 03596010515827: CAP ROTR HDL 5MM INTRCPTR
• 03596010380937: HANDLE RATCHET ASSY INTERCEP
• 03596010380814: TRAY INSERT INTRCPTR INST.