AccessGUDID - DEVICE: HELMUT ZEPF (EZPF19200300)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 19.200.30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19.200.30
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF19200300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: HANDLE, ZEPF BRUSH-HOLDER CURVED 30° FOR INSERTS 10201.10, .20 & .30

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?
12235	Scalpel handle, reusable	A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJB	HANDLE, INSTRUMENT, 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: d9a143f5-771a-4aa8-b896-bfe6cce71e3a
Public Version Date: February 07, 2024
Public Version Number: 2
DI Record Publish Date: November 29, 2022