AccessGUDID - DEVICE: Locking Proximal Femur (00841132146033)

GUDID

Device Identifier (DI) Information

Brand Name: Locking Proximal Femur
Version or Model: Part Number
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01-0907-0207
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00841132146033
Issuing Agency: GS1
Commercial Distribution End Date: September 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: 3.5MM LOCKING SCREW GUIDE - OUTER TUBE

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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, surgical, instrument

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 9c4f1e07-5496-487f-9fc3-d2d47431dd98
Public Version Date: September 30, 2021
Public Version Number: 2
DI Record Publish Date: May 31, 2018