SMARTSTITCH M-CONNECTOR OM-8078

GUDID 00817470007442

SMARTSTITCH SUTURE CART. - ASSOR

Smith & Nephew, Inc.

Arthroscopic suturing unit

• Primary Device ID: 00817470007442
• NIH Device Record Key: 926ef8f8-6587-4557-8ced-6fbf0b3c1833
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTSTITCH M-CONNECTOR
• Version Model Number: OM-8078
• Catalog Number: OM-8078
• 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	00817470007442 [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: 2015-10-08

On-Brand Devices [SMARTSTITCH M-CONNECTOR]

• 00817470007442: SMARTSTITCH SUTURE CART. - ASSOR
• 20817470007439: SMARTSTITCH SUTURE CRT MW BLACK
• 00817470007428: OM-8077EA BLK SMARTSTITCH MAGNUMWIRE
• 20817470007415: SMARTSTITCH SUTURE CART.
• 00817470007404: OM-8076EA CO-BRAID SMARTSTITCH MAGNUMWIR
• 20817470007392: SMARTSTITCH WITH MW WHITE
• 00817470007381: SMARTSTITCH WITH MW WHITE
• 00817470005912: SMARTSTITCH NEEDLE CASSETTE
• 00817470005905: SPEEDSTITCH SUTURE CARTRIDGE FIN
• 20817470005893: SPEEDSTITCH SUTURE CARTRIDGE FIN
• 00817470005882: OM-8086EA SPEEDSTITCH SUTURE CARTRIDGE F
• 20817470005879: SPEEDSTITCH SUTURE CARTRIDGE FIN
• 00817470005868: OM-8085EA SPEEDSTITCH SUTURE CARTRIDGE F
• 00817470005714: SMARTSTITCH M-CONNECTOR PKG. ASS
• 20817470001048: SPEEDSTITCH SC W/BLACK COBRAID MAGWIRE
• 00817470001037: SPEEDSTITCH SUTURE CARTRIDGE WITH BLACK