AccessGUDID - DEVICE: ZERO Profile Interlocking Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™ (00840118116879)

GUDID

Device Identifier (DI) Information

Brand Name: ZERO Profile Interlocking Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™
Version or Model: 8525-24-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLOWER ORTHOPEDICS CORPORATION

Primary DI Number: 00840118116879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078790947 *Terms of Use

Device Description: Intramedullary fixation rod and accessories

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?
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 24 Millimeter
Outer Diameter: 3.5 Millimeter

Device Record Status

Public Device Record Key: c6b0c7bc-ec37-4ca5-bdb4-76d1f1c09915
Public Version Date: February 12, 2024
Public Version Number: 2
DI Record Publish Date: March 19, 2021