AccessGUDID - DEVICE: CT-7 Traction splint (B54111266360)

GUDID

Device Identifier (DI) Information

Brand Name: CT-7 Traction splint
Version or Model: CT-7 Civilian/black
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1126636
Company Name: FARETEC, INC.

Primary DI Number: B54111266360
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626802540 *Terms of Use

Device Description: CT-7 Leg traction splint with orange straps and black case

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
HSP	Splint, Traction

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: 8958b4c4-551e-475d-91b9-e6fd1a7b39f2
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020