AccessGUDID - DEVICE: Halo Systems (05690977308718)

GUDID

Device Identifier (DI) Information

Brand Name: Halo Systems
Version or Model: JT-215
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JT-215
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690977308718
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 139280028 *Terms of Use

Device Description: J TONG SML/MED- No App

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46528	Traction system skull tongs	A device designed to provide traction to the cervical spine by applying an upward longitudinal force from a traction system to the skull that causes hyperextension of the head and neck. It is typically a two-arm pivoted device that is attached to the skull using pins (partially implanted or not); the proximal end includes a mechanism (e.g., an adjustable threaded bolt and nut) responsible for the application of the traction force. It typically includes straps for connection to the traction system and is used in the management/treatment of damage to the cervical spine, aligns vertebral structures and provides stabilization for a cervical spine injury caused by trauma or disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAX	TONG, SKULL FOR TRACTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930021	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: cf5aa420-5cbe-447e-8c2f-f9fed4bc92c4
Public Version Date: July 22, 2020
Public Version Number: 3
DI Record Publish Date: May 16, 2018