AccessGUDID - DEVICE: Streamline MIS Spinal Fixation System (00846468086725)

GUDID

Device Identifier (DI) Information

Brand Name: Streamline MIS Spinal Fixation System
Version or Model: 51-K-WIRE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 51-K-WIRE
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: 00846468086725
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: MIS, 50cm GUIDEWIRE, QTY 1

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?
61467	General external orthopaedic fixation system implantation kit, single-use	A collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXI	PASSER, WIRE, ORTHOPEDIC

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: 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: 3dce0447-b88d-4d1b-98f4-18e279c408fe
Public Version Date: April 08, 2025
Public Version Number: 5
DI Record Publish Date: September 25, 2020