AccessGUDID - DEVICE: HELMUT ZEPF (EZPF19037010)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 19.037.01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19.037.01
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF19037010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: RUBBER-DAM FORCEPS, IVORY, WIDE OF THE JAW 30 MM

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?
35553	Rubber dam punch	A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJG	FORCEPS, RUBBER DAM CLAMP

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: a7a40b72-65c5-410e-b0c3-0be092d157f3
Public Version Date: February 06, 2024
Public Version Number: 2
DI Record Publish Date: November 29, 2022