ComPel XTR OR Gown 75667266

GUDID 00634916089561

OR GWN COMPEL XTR BLUE S/M - (SR 14340)

STANDARD TEXTILE CO., INC.

Surgical gown, reusable

• Primary Device ID: 00634916089561
• NIH Device Record Key: ac9c9750-443b-4fcc-810b-63c6523a0d54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel XTR OR Gown
• Version Model Number: 75667266
• Catalog Number: 75667266
• 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	00634916089561 [Primary]
GS1	10634916089561 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922753

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

Moist Heat or Steam Sterilization

[00634916089561]

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 [ComPel XTR OR Gown]

• 00634916295108: OR GOWN COMPEL XTR KAUM L/XL BLUE - RM (98 8282) USE: 75667265
• 00634916230017: OR GWN COMPEL XTR KAUM L/XL BL - RM (98 8130) USE: 75667265
• 00634916089561: OR GWN COMPEL XTR BLUE S/M - (SR 14340)
• 00634916046427: OR GWN COMPEL XTR RBLUE L/XL - W/MS @ NK (S/R 12227)
• 00634916040036: OR GWN COMPEL XTR RBLUE L/XL - MS @ NECK (S/R 11699)
• 00634916024463: OR GWN COMPL XTR KAUM L/XL BLU - RM (98 6749) USE: 75667265
• 00634916005882: OR GOWN COMPEL XTR RGLBLUE 2XL - W/TAPE TIES
• 00634916005875: OR GWN COMPEL XTR L/XL BLUE - W/TAPE TIES