AccessGUDID - DEVICE: NekSpine System, w/ Extra Large Support (00810105030570)

GUDID

Device Identifier (DI) Information

Brand Name: NekSpine System, w/ Extra Large Support
Version or Model: 1-1011-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPOSITE MANUFACTURING, INC.

Primary DI Number: 00810105030570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947090650 *Terms of Use

Device Description: The NekSpine is intended for relief of back and neck pain, when looking down for extended periods of time, by providing a force that counteracts the effects of gravity on the head. The device is reusable and intended for short-term use

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?
41042	Thoracic spine orthosis	A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPT	Orthosis, Thoracic

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: 9e27a2fc-0cfc-44ed-918d-3fc6328994da
Public Version Date: August 25, 2023
Public Version Number: 1
DI Record Publish Date: August 17, 2023