AccessGUDID - DEVICE: Carriere® Motion Pro™ (00190707103194)

GUDID

Device Identifier (DI) Information

Brand Name: Carriere® Motion Pro™
Version or Model: 425-8RULER-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORTHO ORGANIZERS, INC.

Primary DI Number: 00190707103194
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 062165188 *Terms of Use

Device Description: Carriere Motion Pro Ruler (10/pack)

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):	Yes
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?
57833	Medical ruler, single-use	A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. 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: 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: 107cf307-4c74-4878-800c-fa23e6200c9b
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: January 16, 2024