450P 72200101

GUDID 03596010542199

KIT INTERNATIONAL PAL 450P

Smith & Nephew, Inc.

Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use Laparoscopic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 03596010542199
• NIH Device Record Key: a5681995-663c-45ea-ae0d-c4d33a77e658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 450P
• Version Model Number: 72200101
• Catalog Number: 72200101
• 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: false
• 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	03596010542199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031379

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [450P]

• 00885554013047: KIT U.K. PAL 450P
• 03596010542199: KIT INTERNATIONAL PAL 450P
• 03596010539342: CAMERA CONTROL UNIT PAL 450P