AccessGUDID - DEVICE: Golden Isles Pedicle Screw System (G079C2520000600)

GUDID

Device Identifier (DI) Information

Brand Name: Golden Isles Pedicle Screw System
Version or Model: C25-2000-060
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intelivation, LLC

Primary DI Number: G079C2520000600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037368183 *Terms of Use

Device Description: Curved Titanium Rod

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?
61306	Microplate seal roller IVD	A manually-operated device intended to firmly apply a seal to a microplate. It consists of a cylindrical-shaped roller attached to a handle and is typically made of metal and plastic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System

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: 60 Millimeter

Device Record Status

Public Device Record Key: 9bf25240-c134-442f-a550-726dc91272c8
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 23, 2022