Fenestrated Surgical Drape 96896920

GUDID 00634916349504

Heart Drape, 30 x 34, 1-Ply, Perval Bleach, 10 3/4 x 6 1/2 Rectangular Fenestration, Binding Around Fenestration, Hemmed on All Side

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: 00634916349504
• NIH Device Record Key: 8b81238a-fb9c-4540-8e0e-88e7e6ebd949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenestrated Surgical Drape
• Version Model Number: 96896920
• Catalog Number: 96896920
• 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	00634916349504 [Primary]
GS1	10634916349501 [Unit of Use]
GS1	10634916349504 [Unit of Use]

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

Moist Heat or Steam Sterilization

[00634916349504]

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

On-Brand Devices [Fenestrated Surgical Drape]

• 00634916349504: Heart Drape, 30 x 34, 1-Ply, Perval Bleach, 10 3/4 x 6 1/2 Rectangular Fenestration, Binding Ar
• 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)