Perval Surgical Gown 75666464

GUDID 00634916053616

OR GWN PERVAL PLUS CEIL XL - TT @ WST W/BCODE S/R 12657

STANDARD TEXTILE CO., INC.

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• Primary Device ID: 00634916053616
• NIH Device Record Key: 0ad51e8e-db16-4581-8779-6aefae15bb41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perval Surgical Gown
• Version Model Number: 75666464
• Catalog Number: 75666464
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916053616 [Primary]
GS1	10634916053616 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950504

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

[00634916053616]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-01-29

On-Brand Devices [Perval Surgical Gown]

• 00634916053616: OR GWN PERVAL PLUS CEIL XL - TT @ WST W/BCODE S/R 12657
• 00634916049176: OR GWN PERVAL PLUS CEIL 3XL - TT @ WST W/BCODE S/R 12374
• 00634916041941: OR GWN PERVAL PLUS CEIL XL - TT @ WST W/BCODE S/R 11874
• 00634916041934: OR GWN PERVAL PLUS CEIL L - TT @ WST W/BCODE S/R 11874