Steri-Drape™ Ioban™ 2 6617

GUDID 50707387444346

6617 IOBAN II PATIENT ISOLATION DRAPE 5/BX,4BX/CS

3M COMPANY

Patient surgical drape, single-use, sterile

• Primary Device ID: 50707387444346
• NIH Device Record Key: 01582b82-09a8-4692-8ade-ccd81b5ff54f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steri-Drape™ Ioban™ 2
• Version Model Number: 6617
• Catalog Number: 6617
• Company DUNS: 830016148
• Company Name: 3M COMPANY
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00707387444341 [Unit of Use]
GS1	30707387444342 [Primary]
GS1	50707387444346 [Package]; Contains: 30707387444342; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801550

FDA Product Code

• KKX: Drape, surgical

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: 2018-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Steri-Drape™ Ioban™ 2]

• 50707387773965: 3M™ Steri-Drape™ Cesarean-Section Drape with Ioban™ 2 Incise Film and Clear Screen 6697CA
• 50707387579598: 3M™ Steri-Drape™ Craniotomy Drape Pack with Ioban™ 2 Incise Pouch 6687P
• 50707387579581: 3M™ Steri-Drape™ Cardiovascular Drape Pack with Ioban™ 2 Incise Film 6677P
• 50707387568141: 3M™ Steri-Drape™ Cardio / Chest Drape with Ioban™ 2 Incise Film, 8 per Case, 6682
• 50707387565539: 3M™ Steri-Drape™ Craniotomy Drape with Ioban™ 2 Incise Pouch 6687
• 50707387444445: 3M™ Steri-Drape™ Cesarean-Section Sheet and Pouch with Ioban™ 2 Incise Film 6697
• 50707387444353: 6619 2 PTNT ISO SYS INCISE AREA<(>&<)>P
• 50707387381740: 3M™ Steri-Drape™ Abdominal-Perineal Drapes 6665
• 50707387381719: 3M™ Steri-Drape™ Cardiovascular Sheet with Ioban™ 2 Incise Film 6681
• 50707387229646: 3M™ Steri-Drape™ Cardiovascular Sheet with Ioban™ 2 Incise Film 6677
• 50707387771589: 3M™ Steri-Drape™ Caesarean-Section Kit, 5 Per Carton, 2 Cartons Per Case 6697P001
• 50707387771572: 3M™ Steri-Drape™ Vertical Isolation Drape Kit, 8 Per Carton, 2 Cartons Per Case 6619P001
• 50707387771565: 3M™ Steri-Drape™ Vertical Isolation Drape Kit, 9 Per Carton, 2 Cartons Per Case 6617P001
• 50707387469851: 3M™ Steri-Drape™ Pouch with Ioban™ 2 Incise Film, Extra Large 6659
• 50707387444438: 6658 2 INCISE POUCH 5/BX4BX/CS
• 50707387444421: 3M™ Steri-Drape™ Pouch with Ioban™ 2 Incise Film 6657
• 50707387444346: 6617 IOBAN II PATIENT ISOLATION DRAPE 5/BX,4BX/CS