AccessGUDID - DEVICE: FlexiOH (08908014765002)

GUDID

Device Identifier (DI) Information

Brand Name: FlexiOH
Version or Model: Short Arm Immobilizer XXS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JC ORTHOHEAL PRIVATE LIMITED

Primary DI Number: 08908014765002
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 877234002 *Terms of Use

Device Description: FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fracture and wrist sprain.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
41457	Hand orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQI	Orthosis, Limb Brace

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
Special Storage Condition, Specify: Protect from direct sun light

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: XXS

Device Record Status

Public Device Record Key: 6dec5c9e-4816-4e2a-92a9-4debe61390d7
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: June 29, 2020