AccessGUDID - DEVICE: Guardian Splint (08809818038197)

GUDID

Device Identifier (DI) Information

Brand Name: Guardian Splint
Version or Model: GSACU-LL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BM KOREA CO., LTD

Primary DI Number: 08809818038197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557799209 *Terms of Use

Device Description: This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.

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?
48071	Assistive dynamic arm support system	An assembly of mechanical devices designed to bear the weight of a weak or paralysed arm providing gravity-compensating support for the functional use and/or rehabilitation of the arm/wrist/hand. It is used to support activities of daily life (ADL) such as feeding, self care, computer use, as well as therapeutical training and prevention of complaints of neck and/or shoulder (CANS). It consists of a main column anchored to a surface or wheelchair and a suspended sling or a set of components which take the weight bearing through a set of axes, joints, and a splint underneath the user's arm. Gravity compensation works via a counterweight or spring mechanism and a power-assistive electromotor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILH	Splint, Hand, And Components

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
Length: 230 Millimeter
Width: 95 Millimeter

Device Record Status

Public Device Record Key: 2a0f24a8-d31c-4f75-bc58-5f4e5e60ca52
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 21, 2025