ComPel Surgical Drapes 95869545

GUDID 00634916010893

TABLE COVER COMPEL XTR 45X70 - 1PLY XTR

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile General-purpose surgical drape, reusable, sterile Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable Patient surgical drape, reusable

• Primary Device ID: 00634916010893
• NIH Device Record Key: 1e5d8538-d132-43a1-bd87-15872c3669b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Surgical Drapes
• Version Model Number: 95869545
• Catalog Number: 95869545
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 12
• 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	00634916010893 [Primary]
GS1	10634916010893 [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

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

Moist Heat or Steam Sterilization

[00634916010893]

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 Surgical Drapes]

• 00634916024968: TABLE COVER SM 60X72 BLUE - BARCODE 95-9026 (SR 10654)
• 00634916010893: TABLE COVER COMPEL XTR 45X70 - 1PLY XTR