AccessGUDID - DEVICE: TRUFIX Bone Fixation System (00614950006175)

GUDID

Device Identifier (DI) Information

Brand Name: TRUFIX Bone Fixation System
Version or Model: 45428001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45428001
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950006175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: * SURGICAL BONE PLATE 8-HOLES .6MM THICK ORBITAL SHAPE 43TL

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?
47996	Orthodontic anchor plate	A small metallic plate that is implanted intraorally to serve as a temporary anchor for an orthodontic device (e.g., a spring). It is available in various sizes and lengths and is anchored to the jawbone with dedicated bone screws. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OAT	Implant, endosseous, orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951392	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 43 Millimeter

Device Record Status

Public Device Record Key: c3f9aece-6f5d-4185-beb6-83b59d306ddf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 28, 2017