Standard Supreme Drape 95280252

GUDID 00634916005363

SPINAL SHEET W/QCM 3 SPECIAL - 34X34 1PLY STD SUP W/REIN CO

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile

• Primary Device ID: 00634916005363
• NIH Device Record Key: b0cb3859-3821-40c3-89cc-c9dc87bbf272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Supreme Drape
• Version Model Number: 95280252
• Catalog Number: 95280252
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 48
• 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	00634916005363 [Primary]
GS1	10634916005360 [Unit of Use]
GS1	10634916005363 [Unit of Use]

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

Moist Heat or Steam Sterilization

[00634916005363]

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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• 00634916256970: SHT OPEN HEART 25X66 MISTY - 2PLY STD SUPREME (SR 17334)
• 00634916091052: SPINAL DRAPE SHEET STANDARD SUPREME MISTY 28X32 - 2PLY STD SUP W/3X3 BND FEN
• 00634916045383: SPINAL DRAPE SHEET 29X29 JADE SPECIAL - 29X29 1 PLY STD SUP (SR 12196)
• 00634916018141: ARM SHEETS STANDARD SUPREME 31X60 MISTY - 31X60 2PLY
• 00634916018134: Standard Supreme RECTANG LEGGING T-180 JADE - 12X36 T-180 SINGLE PLY
• 00634916012422: DRAPE EYE 30X30 JADE - 2PLY STANDARD SUPREMEW/FEN PRO#723.0
• 00634916010374: GOITER SHEET MISTY 72X90 - 1 PLY STD SUPREME HEMMED
• 00634916007770: EYE DRAPE 18X18 MISTY - 1PLY STANDARD SUPREME W/REIN (S/R 12161)
• 00634916005363: SPINAL SHEET W/QCM 3 SPECIAL - 34X34 1PLY STD SUP W/REIN CO
• 00634916005356: PERI SHEET STD SUPREME 49X70 - 1PLY STD S W/REIN-CO
• 00634916000016: Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Poc