AccessGUDID - DEVICE: Halo Systems (05690977308688)

GUDID

Device Identifier (DI) Information

Brand Name: Halo Systems
Version or Model: 515400V2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 515400V2
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690977308688
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: OB V2 RING KIT TI STD-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?
46537	Cervical spine immobilization head ring	A loop (halo) that is part of a cervical spine immobilization system (commonly known as a Halo vest) and designed to be fixed to the skull of a patient at brow level using pointed, steel, threaded bolts (typically four) that are adjusted to penetrate the outer bone of the skull. Vertical, adjustable rods from the Halo vest are locked to this loop, and a traction upon the cervical spine is created, holding the head firmly in place relative to the torso so that cervical vertebrae are immobilized following surgery or injury. It may be made of ferrous or non-ferromagnetic materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAX	TONG, SKULL FOR TRACTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051918	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: a1cd1b14-b706-4460-a93c-9789f99480a0
Public Version Date: July 22, 2020
Public Version Number: 3
DI Record Publish Date: May 16, 2018