AccessGUDID - DEVICE: Doran Scales (00850013361281)

GUDID

Device Identifier (DI) Information

Brand Name: Doran Scales
Version or Model: PC500-05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PC500-05
Company Name: DORAN SCALES, INC.

Primary DI Number: 00850013361281
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 021437579 *Terms of Use

Device Description: Diaper and Specimen Scale 5x0.002lb (2300x1g)

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):	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?
40494	Medical/surgical procedure scale, electronic	An electronic device designed to weigh body tissues and/or clinical objects [e.g., dressings, surgical sponges, nappies (diapers)] in association with a medical/surgical procedure and/or at autopsy. It is not intended to weigh a patient (including infants), and is not intended for laboratory use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQA	Scale, Surgical Sponge

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: 32dbe41f-035f-4a5b-ac8a-a1ced31564be
Public Version Date: January 01, 2024
Public Version Number: 3
DI Record Publish Date: May 31, 2022