AccessGUDID - DEVICE: HELMUT ZEPF (EZPF24725070)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 24.725.07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24.725.07
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF24725070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: PERIODONTAL SCALER, DOUBLE-ENDED, 45° / 90°, EXCHANGEABLE INSETS,

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":	Yes
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?
41876	Endodontic plugger	A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMN	SCALER, PERIODONTIC

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: 205c5384-1f91-40b1-b9c1-f0387e143258
Public Version Date: January 23, 2024
Public Version Number: 2
DI Record Publish Date: December 02, 2022