AccessGUDID - DEVICE: XULTAN ROD HOLDER (00819824023818)

GUDID

Device Identifier (DI) Information

Brand Name: XULTAN ROD HOLDER
Version or Model: 30290318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30290318
Company Name: MET 1 TECHNOLOGIES, LLC

Primary DI Number: 00819824023818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080474650 *Terms of Use

Device Description: THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.

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):	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?
47807	Surgical implant/trial-implant/sizer holder, reusable	A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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 [?]
K170108	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: 18e8721b-8e15-4ed6-8f74-bd3f931f963d
Public Version Date: July 31, 2024
Public Version Number: 3
DI Record Publish Date: March 29, 2018