AccessGUDID - DEVICE: HELMUT ZEPF (EZPF26182450)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 26.182.45
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 26.182.45
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF26182450
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: GIN-KNIFE KIT CONSISTING OF: 26.182.38/ 26.182.39/ 26.182.40 IN TRAY 85.182.00

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:	Yes
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: 930a5b8b-88f9-42e7-909f-dfec860f2fc8
Public Version Date: May 03, 2024
Public Version Number: 1
DI Record Publish Date: April 25, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49742498880
Email: info@zepf-dental.com

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