AccessGUDID - DEVICE: DARCO® Night Splint (00609271809758)

GUDID

Device Identifier (DI) Information

Brand Name: DARCO® Night Splint
Version or Model: NW2B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NW2B; NS2B
Company Name: DARCO INTERNATIONAL, INC.

Primary DI Number: 00609271809758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184231298 *Terms of Use

Device Description: Medium Black with Wedge

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):	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?
32302	Inflatable extremity splint	A non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. 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
No Device Sizes

Device Record Status

Public Device Record Key: 55bf6d5e-bfa0-42cb-bc0d-a0d2de1b67fb
Public Version Date: February 16, 2023
Public Version Number: 1
DI Record Publish Date: February 08, 2023