012604

GUDID 03596010078810

CANN LUM DB CRVD L/R

Smith & Nephew, Inc.

Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable Rigid endoscopic cannula, reusable

• Primary Device ID: 03596010078810
• NIH Device Record Key: cd5f7b33-088d-4a5b-85ba-62b83b94c2c0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 012604
• Catalog Number: 012604
• 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)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	03596010078810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830719

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

[03596010078810]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

• 00885556902738 - INTELLIO SHIFT: 2024-05-15 NEO CONTROLLER REFURBISH
• 00885556630761 - Q-FIX: 2024-05-14 DISPOSABLE 1.8MM Q-FIX DRILL
• 00885556630785 - Q-FIX: 2024-05-14 REUSABLE 1.8MMQ-FIX DRILL GUIDE
• 00885556918333 - R3: 2024-05-10 FEMORAL OSTEOTOMY RULER
• 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