AccessGUDID - DEVICE: PYRENEES® Cervical Plate System (10888857113138)

GUDID

Device Identifier (DI) Information

Brand Name: PYRENEES® Cervical Plate System
Version or Model: 5901-15018C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5901-15018C
Company Name: K2M, INC.

Primary DI Number: 10888857113138
Issuing Agency: GS1
Commercial Distribution End Date: October 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 146060863 *Terms of Use

Device Description: Screw, Self-Tapping Size Ø5.0x18 mm

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):	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?
45212	Multi-modality skin contouring system applicator, infrared light	A device that is part of a skin contouring system that is used to apply an energy consisting of infrared light to the skin of a patient to temporarily minimize the manifestation of cellulite, loose or wrinkled skin. This device is connected to an energy-producing generator and is moved across a patient's skin by a practitioner or staff for treatment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 18 Millimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 3eff9261-c905-49e2-8d4c-aa4d6291c662
Public Version Date: September 01, 2025
Public Version Number: 8
DI Record Publish Date: January 23, 2017