AccessGUDID - DEVICE: FibreKleer 4x (10814978023322)

GUDID

Device Identifier (DI) Information

Brand Name: FibreKleer 4x
Version or Model: N83C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kerr Corporation

Primary DI Number: 10814978023322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 18
Labeler D-U-N-S® Number*: 199354556 *Terms of Use

Device Description: Fiber Post Shape Original 5x 1.00 mm 1.25 mm 1.50 mm Posts; 1x 1.00 mm, 1.25 mm, 1.50 mm Drills

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?
38609	Root canal post, preformed	A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELR	POST, ROOT CANAL

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
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5x 1.00 mm, 5x 1.25 mm, and 5x 1.50 mm Fiber Posts; 1x 1.00 mm, 1x 1.25 mm, and 1x 1.50 mm Drill

Device Record Status

Public Device Record Key: 3b493dc6-96c9-4884-bc11-5d56da8b6300
Public Version Date: December 09, 2021
Public Version Number: 3
DI Record Publish Date: September 12, 2016