SMARTSTITCH PERFECTPASSER OM-8175

GUDID 20817470005800

SMARTSTITCH PERFECTPASSER SUTURE CARTRID

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

• Primary Device ID: 20817470005800
• NIH Device Record Key: ea9539b5-bd5d-4389-93e1-1059954e8fef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTSTITCH PERFECTPASSER
• Version Model Number: OM-8175
• Catalog Number: OM-8175
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470005806 [Primary]
GS1	20817470005800 [Package]; Contains: 00817470005806; Package: BX [6 Units]; In Commercial Distribution

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

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