AccessGUDID - DEVICE: GAESCA (00850051333011)

GUDID

Device Identifier (DI) Information

Brand Name: GAESCA
Version or Model: Gaesca Aluminium Elbow Crutches Gray (Pair)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mp2g Diagnostic Corp

Primary DI Number: 00850051333011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 048991263 *Terms of Use

Device Description: Aluminium Elbow Crutches (Pair) Gray

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?
31113	Elbow crutch	A staff-like mobility aid designed to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and a non-horizontal plastic or metal cuff that wraps around the forearm. The handgrip is typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). It may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is commonly used by long-term crutch users because of its lightweight and energy preservation qualities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPS	Cane

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: 0be3b3e7-4b96-468c-8b93-e7556d9eb442
Public Version Date: May 12, 2023
Public Version Number: 1
DI Record Publish Date: May 04, 2023