Fenestrated Surgical Drape 95989574

GUDID 00634916028218

DRAPE CIRCUMCISION CEIL 17X17 - W/3/4" RND FEN (S/R 11101)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile

• Primary Device ID: 00634916028218
• NIH Device Record Key: f298b0d9-9628-4045-ad9e-27fc3b23c38e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenestrated Surgical Drape
• Version Model Number: 95989574
• Catalog Number: 95989574
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 144
• DM Exempt: false
• Pre-market Exempt: true
• 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	00634916028218 [Primary]
GS1	10634916028218 [Unit of Use]

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

[00634916028218]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-29

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• 00634916307832: DRAPE MULTI PURPOSE 13X17 CEIL - T180 ATCHD PAD 3"FEN (SR17813)
• 00634916307825: DRAPE MULTI PURPOSE 13X17 JADE - T180 ATCHD PAD 5"FEN (SR17814)
• 00634916247039: DRAPE SURGICAL MISTY 18X18 - 2PLY T-180 W/FEN (S/R 17103)
• 00634916232387: DRAPE T180 25X25 CEIL BLUE - W/5" SQUARE FEN (S/R 16988)
• 00634916232141: DRAPE CIRCUMCISION 17X13 CEIL - W/1" ROUND FEN (S/R 16900)
• 00634916186925: DRAPE CIRCUMCISION 18X24 BLEA - 1PLY T180 W/FEN (SR 14998)
• 00634916028218: DRAPE CIRCUMCISION CEIL 17X17 - W/3/4" RND FEN (S/R 11101)