AccessGUDID - DEVICE: FRC Postec Plus Refill (DIVO590223AN1)

GUDID

Device Identifier (DI) Information

Brand Name: FRC Postec Plus Refill
Version or Model: 590223AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 590223AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO590223AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: August 23, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: FRC Postec Plus

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: 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: f29d638b-ac27-4424-a94b-12bfba63839c
Public Version Date: August 25, 2023
Public Version Number: 2
DI Record Publish Date: August 26, 2020