ComPel XTR OR Gown 7566U685

GUDID 00634916295108

OR GOWN COMPEL XTR KAUM L/XL BLUE - RM (98 8282) USE: 75667265

STANDARD TEXTILE CO., INC.

Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable

• Primary Device ID: 00634916295108
• NIH Device Record Key: 337037e2-5253-4da1-8383-c2a171de07ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel XTR OR Gown
• Version Model Number: 7566U685
• Catalog Number: 7566U685
• 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	00634916295108 [Primary]
GS1	10634916295108 [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

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

Moist Heat or Steam Sterilization

[00634916295108]

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