AccessGUDID - DEVICE: PMT® Halo Systems (00650551109136)

GUDID

Device Identifier (DI) Information

Brand Name: PMT® Halo Systems
Version or Model: 1208-164
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1208-164
Company Name: PMT CORPORATION

Primary DI Number: 00650551109136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: HALO, 1203-5 VEST SMALL, LAMBSWOOL LINER, 1208-1 LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-11 TRACTION BAIL

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":	Yes
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?
60367	Cervical spine immobilization system, single-use	An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HAX	Tong, Skull For Traction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090733	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c67df9a7-a53e-43eb-9f59-beeacb6e429e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: November 09, 2017