ComPel Mayo Stand Cover 27751552

GUDID 00634916005578

COMPEL LARGE MAYO STAND COVER - 26X61 2PLY-MERROWED (SR 11853)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile

• Primary Device ID: 00634916005578
• NIH Device Record Key: 071c4509-e402-48f6-8b71-bf2c0e69d7a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Mayo Stand Cover
• Version Model Number: 27751552
• Catalog Number: 27751552
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 36
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916005578 [Primary]
GS1	10634916005578 [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

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

Moist Heat or Steam Sterilization

[00634916005578]

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

Devices Manufactured by STANDARD TEXTILE CO., INC.

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• 00634916099225 - INSTRUMENT COVER: 2026-03-19 Instrument Cover, 2 Ply T-180, 55% Cotton, 45% Polyester
• 00634916120905 - Instrument Holder: 2026-03-19 Wrappel Instrument Holder with Pockets, 100% Polyester
• 00634916349740 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER.
• 00634916781373 - WrapPel Table Cover: 2026-03-19 WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER'
• 00634916788105 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788112 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788129 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER