DermaTherapy Fitted Sheet

GUDID 10634916508960

DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10

STANDARD TEXTILE CO., INC.

Absorbent underpad, non-antimicrobial, reusable

• Primary Device ID: 10634916508960
• NIH Device Record Key: 0f7c9bb7-f9a8-4cbb-9922-6d88925f323f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaTherapy Fitted Sheet
• Version Model Number: 17810100
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• 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	00634916508963 [Primary]
GS1	10634916508960 [Unit of Use]

FDA Product Code

• FMW: Cover, Mattress (Medical Purposes)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-28
• Device Publish Date: 2020-08-24

On-Brand Devices [DermaTherapy Fitted Sheet]

• 10634916578710: DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around with Blue T
• 10634916508960: DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10