AccessGUDID - DEVICE: OrthoPediatrics PediFlex Flexible Nail System (00841132119624)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoPediatrics PediFlex Flexible Nail System
Version or Model: 00-1000-530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-1000-530
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00841132119624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: ø3.0mm x 400mm Round Tip Flexible IM Nail

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?
33187	Femur intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	PIN, FIXATION, SMOOTH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081097	000

Device Exempt from Premarket Submission: No 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: 25c903e1-1e39-46f8-a3f7-9057d903ef9e
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: September 08, 2015