AccessGUDID - DEVICE: Halo Systems (05690977192577)

GUDID

Device Identifier (DI) Information

Brand Name: Halo Systems
Version or Model: 517DS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 517DS
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690977192577
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: Skull Pin 3in CT Sterl 4 PK

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:	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?
46664	Cervical spine immobilization head ring rod	An implantable, threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level. Commonly referred to as a pin, it is typically made of metal (e.g., stainless steel), may be ceramic-tipped, or made of non-ferromagnetic materials. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYT	FIXATION ACCESSORY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040363	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: 30e4644c-b686-4432-88b9-2c410c9529ab
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: May 16, 2018