SMARTSTITCH M-CONNECTOR OM-8086

GUDID 20817470005893

SPEEDSTITCH SUTURE CARTRIDGE FIN

Smith & Nephew, Inc.

Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit

• Primary Device ID: 20817470005893
• NIH Device Record Key: 917f7280-3b9e-46da-a9f7-5700fcf7ae30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTSTITCH M-CONNECTOR
• Version Model Number: OM-8086
• Catalog Number: OM-8086
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470005899 [Primary]
GS1	20817470005893 [Package]; Contains: 00817470005899; Package: BX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042031

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-13

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