AccessGUDID - DEVICE: HELMUT ZEPF (EZPF1700705TI0)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 17.007.05TI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17.007.05TI
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF1700705TI0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: X-DESMO-TOOL, ROOT-ELEVATOR 4,0MM, WITH GOLDEN ID.-BALL ONYX COATING

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?
16480	Dental elevator, tooth/root	A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMJ	ELEVATOR, SURGICAL, DENTAL

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: a83e7dbb-d962-49ed-b987-7c78f2bcf921
Public Version Date: February 19, 2024
Public Version Number: 2
DI Record Publish Date: November 28, 2022