AccessGUDID - DEVICE: CUSTOMED (M20810063642)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOMED
Version or Model: OR TURNOVER DRAPE WITH TRANSFER SHEET
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1006364
Company Name: CUSTOMED INC

Primary DI Number: M20810063642
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 627572217 *Terms of Use

Device Description: OR TURNOVER DRAPE WITH TRANSFER SHEET

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	Bedding, Disposable, Medical

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: d18df89b-8e11-4061-9452-cf4639dd77a9
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023