AccessGUDID - DEVICE: X-STOP® Interspinous Spacer (00643169132825)

GUDID

Device Identifier (DI) Information

Brand Name: X-STOP® Interspinous Spacer
Version or Model: 1-3212
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169132825
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: SPACER 1-3212 US 12MM X-STOP PEEK

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61531	Lumbar decompression interspinous spacer	A device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NQO	Prosthesis, spinous process spacer/plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040001	020

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Minor Diameter 12mm

Device Record Status

Public Device Record Key: 83d4b3a6-ec2b-4bf2-9754-1544a2c9cc7e
Public Version Date: September 13, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2014