AccessGUDID - DEVICE: DermaTherapy Fitted Sheet (00634916578713)

GUDID

Device Identifier (DI) Information

Brand Name: DermaTherapy Fitted Sheet
Version or Model: 17810500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916578713
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2024
Device Count: 24
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around with Blue Thread, 35x84x11

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66117	Absorbent underpad, non-antimicrobial, reusable	A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMW	Cover, Mattress (Medical Purposes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5d440d0-3698-485c-a5e9-be27282c45c3
Public Version Date: June 17, 2024
Public Version Number: 3
DI Record Publish Date: August 24, 2020