AccessGUDID - DEVICE: Measure-it® (00809958051603)

GUDID

Device Identifier (DI) Information

Brand Name: Measure-it®
Version or Model: 59901
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DUP59901
Company Name: Derma Sciences Canada Inc

Primary DI Number: 00809958051603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: Wound measuring kit. Contains one 0.26 in X 7.563 Measure-It plastic ruler and one 7 in X 1.5 in Measure-It Wound paper depth guide

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:	Yes
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?
44866	Wound measure	A device designed to determine the dimensions of a wound typically to document changes in wound size during the healing process. The device may be a simple ruler or similar measuring device and/or a tracing film to outline a wound that may utilize an electronic digital tablet to calculate wound area or other dimensions (e.g., length, width, depth). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTY	TAPE, MEASURING, RULERS AND CALIPERS

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: Yes
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: bfd0f4ab-0f64-456f-9bfc-6239846b69de
Public Version Date: June 25, 2024
Public Version Number: 2
DI Record Publish Date: October 23, 2018