AccessGUDID - DEVICE: HELMUT ZEPF (EZPF46040150)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 46.040.15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 46.040.15
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF46040150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: PALATAL KNIFE TO REMOVE CONNECTIVE TISSUE ACC. TO DR. MIZANI

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?
42338	Syndesmotome	A hand-held, dental, surgical instrument designed for cutting desmodontal fibres and for detaching the alveolodental ligaments (the fibrous connective tissue surrounding the root of a tooth that separates it from and attaches it to the alveolar bone). It is typically made of high-grade stainless steel and has a long shaft with a handle at the proximal end and an angled scythe-like or knife-like blade at the distal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMO	KNIFE, 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: b431b487-b980-4ac8-bef0-9c6bb83f997a
Public Version Date: December 12, 2023
Public Version Number: 2
DI Record Publish Date: December 07, 2022