AccessGUDID - DEVICE: Minimally Invasive Deformity Correction (MID-C) System (07290018128411)

GUDID

Device Identifier (DI) Information

Brand Name: Minimally Invasive Deformity Correction (MID-C) System
Version or Model: Extender- Lenke 1 Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EUS-055-002
Company Name: APIFIX LTD

Primary DI Number: 07290018128411
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649220688 *Terms of Use

Device Description: No description.

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?
67285	Mechanical spinal distraction rod extender	An implantable, metallic device in the form of a short, fixed length rod intended to be optionally connected to the upper end of a mechanical spinal distraction rod (not included) to increase its length to provide greater load distribution (e.g., when the patient has small pedicles) as part of scoliosis treatment. It is not intended to be implanted without the parent rod. It has a U-shaped end, which may be straight or angled, to allow connection to the parent rod; it is designed to be fixed to the parent rod and vertebrae using bone screws.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGP	Posterior Ratcheting Rod System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H170001	003

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
No Device Sizes

Device Record Status

Public Device Record Key: 4698f888-6498-418c-a950-64782fae6996
Public Version Date: September 02, 2024
Public Version Number: 2
DI Record Publish Date: June 29, 2021