AccessGUDID - DEVICE: FRC Postec Plus Reamer (DIVO572800AN1)

GUDID

Device Identifier (DI) Information

Brand Name: FRC Postec Plus Reamer
Version or Model: 572800AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 572800AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO572800AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: November 04, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: FRC Postec Plus Reamer Refill Size 3

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?
64833	Endodontic instrument-holding insert, reusable	A device intended to be fitted into a container designed to store endodontic instruments (e.g., files/rasps), typically chairside prior to a clinical procedure or during a sterilization procedure. It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKP	REAMER, PULP CANAL, ENDODONTIC

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: ae73c49e-f6b7-4610-a84f-dc5e8f9ae28e
Public Version Date: November 05, 2024
Public Version Number: 2
DI Record Publish Date: August 26, 2020