AccessGUDID - DEVICE: Guardian Splint (08809818038159)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 08809818038159
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?
64250	First aid limb splint, non-mouldable, reusable	A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It consists of an unpadded, non-mouldable rigid portion which is applied externally to the limb and held in place with straps/ropes, and may be capable or applying traction; it is made of a variety of materials, and may be used in the home or by emergency medical services (EMS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile

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: 355 Millimeter
Width: 120 Millimeter

Device Record Status

Public Device Record Key: a206ca7c-2e9c-4303-9573-df347505ea76
Public Version Date: March 28, 2025
Public Version Number: 1
DI Record Publish Date: March 20, 2025