AccessGUDID - DEVICE: FS3 Facet Screw Spinal System (00190837041212)

GUDID

Device Identifier (DI) Information

Brand Name: FS3 Facet Screw Spinal System
Version or Model: 144-018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 144-018
Company Name: Life Spine, Inc.

Primary DI Number: 00190837041212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183641617 *Terms of Use

Device Description: Access Needle Sheath

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?
60478	Bone access cannula	A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRW	SYSTEM, FACET SCREW SPINAL DEVICE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090865	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: dec31285-de5f-4940-a8c3-824c30a460f1
Public Version Date: September 02, 2024
Public Version Number: 2
DI Record Publish Date: November 07, 2019