Comply™ SteriGage™ 41360

GUDID 50707387469172

41360 TEST PACK 4PK/BG 4BG/BX 4BX/CS

3M COMPANY

Chemical/physical sterilization process indicator

• Primary Device ID: 50707387469172
• NIH Device Record Key: a1e9c940-e32a-4ebb-8987-f6a62262f992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comply™ SteriGage™
• Version Model Number: 41360
• Catalog Number: 41360
• Company DUNS: 830016148
• Company Name: 3M COMPANY
• Device Count: 16
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00707387469177 [Unit of Use]
GS1	30707387469178 [Primary]
GS1	50707387469172 [Package]; Contains: 30707387469178; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894399

FDA Product Code

• FRC: Indicator, biological sterilization process

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Comply™ SteriGage™]

• 50707387769241: 3M™ Comply™ Steri-Gage™ Chemical Indicator with Extension 1243RE
• 50707387457032: 3M™ Comply™ (SteriGage™) Sterilization Integrator Load Record Cards 4171MM
• 50707387469172: 41360 TEST PACK 4PK/BG 4BG/BX 4BX/CS
• 50707387469080: 1243B 3M COMPLY STEAM CHEMICAL INTEGRATOR 100/PK 10PK/CS
• 50707387469073: 3M™ Comply™ (SteriGage™) Chemical Integrator 1243A