AccessGUDID - DEVICE: n/a (E0HM649755F2040401)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: 9755F 040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 803204297502040
Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Primary DI Number: E0HM649755F2040401
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 318034329 *Terms of Use

Device Description: Rotary polisher for dental application

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?
63517	Dental abrasive point, single-use	A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHL	POINT, ABRASIVE

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: d9abd0d7-f0f2-417c-b648-0d67c717b55b
Public Version Date: September 23, 2021
Public Version Number: 1
DI Record Publish Date: September 15, 2021