AccessGUDID - DEVICE: OrthoSolutions 'System26' Bone Screws (05055662950458)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoSolutions 'System26' Bone Screws
Version or Model: OS914045-NS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OS914045-NS
Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED

Primary DI Number: 05055662950458
Issuing Agency: GS1
Commercial Distribution End Date: February 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 218648211 *Terms of Use

Device Description: 6.5MM X 45MM HEADED CANNULATED SCREW 30MM THREAD

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:	Yes
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?
66497	Stress-therapy vibroacoustic headband	An electrically-powered wearable device intended to apply vibroacoustic therapy (VAT) stimuli to the head to treat stress and sleep disorder symptoms (e.g., insomnia, migraine, anxiety) by inducing a state of brain relaxation. It is typically in the form of a headband to be positioned over the forehead and temporal areas of the head, and includes dedicated software for vibration frequency programming from a wirelessly connected smart device (not included). It is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163489	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a47115dc-fcf3-4bbf-94b8-51eeccdfaf45
Public Version Date: June 23, 2025
Public Version Number: 5
DI Record Publish Date: March 20, 2017