SMARTSTITCH PERFECTPASSER OM-8177EA

GUDID 00817470001105

SMARSTITCH PP MW BLACK COBRAID

Smith & Nephew, Inc.

Arthroscopic suturing unit

• Primary Device ID: 00817470001105
• NIH Device Record Key: 8470493a-9044-48c9-8cb3-4ad4f60636bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTSTITCH PERFECTPASSER
• Version Model Number: OM-8177EA
• Catalog Number: OM-8177EA
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• 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	00817470001105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123268

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-09-21

On-Brand Devices [SMARTSTITCH PERFECTPASSER]

• 00817470006971: SMARTSTITCH PP CONNECTOR
• 00817470005844: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• 00817470005837: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• 20817470005824: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• 00817470005813: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• 20817470005800: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• 20817470001116: SMARSTITCH PP MW BLACK COBRAID
• 00817470001105: SMARSTITCH PP MW BLACK COBRAID