AccessGUDID - DEVICE: HELMUT ZEPF (EZPF85251100)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 85.251.10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85.251.10
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF85251100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: CUP, PROPHYLAXIS LID ONLY, FOR MIXING CUP 85.251.04 MADE OF POM

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?
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHK	CUP, PROPHYLAXIS

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: 2c3b7578-cf8f-4be5-bcf7-110a1dc8901a
Public Version Date: December 12, 2023
Public Version Number: 2
DI Record Publish Date: December 09, 2022