AccessGUDID - DEVICE: FREE GLIDING SCFE SCREW SYSTEM (07540194007988)

GUDID

Device Identifier (DI) Information

Brand Name: FREE GLIDING SCFE SCREW SYSTEM
Version or Model: SCF-SFT273
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCF-SFT273
Company Name: Orthopediatrics Canada ULC

Primary DI Number: 07540194007988
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243298854 *Terms of Use

Device Description: SCFE DRIVER THREAD Ø7.3mm - MINI

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?
47779	Orthopaedic instrument surgical connector	A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXX	SCREWDRIVER

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
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 2.5 Millimeter

Device Record Status

Public Device Record Key: 4145563a-659f-4f70-a0d8-60d1e9d6e71a
Public Version Date: May 13, 2025
Public Version Number: 4
DI Record Publish Date: August 12, 2020