ComPel XTR Mayo Cover 95869715

GUDID 00634916055863

COMPEL XTR MAYO COVER 28X54 - (S/R 12669)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile

• Primary Device ID: 00634916055863
• NIH Device Record Key: a2504328-fccc-4bb9-aca3-65c5d33738d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel XTR Mayo Cover
• Version Model Number: 95869715
• Catalog Number: 95869715
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916055863 [Primary]
GS1	10634916055860 [Unit of Use]
GS1	10634916055863 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923811

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

[00634916055863]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-29

On-Brand Devices [ComPel XTR Mayo Cover]

• 00634916055863: COMPEL XTR MAYO COVER 28X54 - (S/R 12669)
• 00634916024951: MAYO COVER COMPEL XTR 22X54 - REIN 30"L BARCODE 95-9026
• 00634916001181: COMPEL XTR MAYO COVER XTR/W - 22X54 REIN 30"L