AccessGUDID - DEVICE: MCI - Medical Concept Innovation, Inc. (00811687031047)

GUDID

Device Identifier (DI) Information

Brand Name: MCI - Medical Concept Innovation, Inc.
Version or Model: A02.01.0802
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A02.01.0802
Company Name: MCI-MEDICAL CONCEPT INNOVATION INC

Primary DI Number: 00811687031047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080815653 *Terms of Use

Device Description: SLIM TRANSBUCCAL HANDLE

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?
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
GAD	Retractor

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a69a001c-cecf-4a2f-a80c-cd68f26fd7e2
Public Version Date: November 07, 2022
Public Version Number: 1
DI Record Publish Date: October 28, 2022