AccessGUDID - DEVICE: MultiCup™ Threaded plug (04048266010995)

GUDID

Device Identifier (DI) Information

Brand Name: MultiCup™ Threaded plug
Version or Model: For MultiCup™
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HF30200
Company Name: Merete GmbH

Primary DI Number: 04048266010995
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 313267265 *Terms of Use

Device Description: MultiCup™ Threaded plug Locking PressFit Cup TiAl6V4 ELI sterile

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":	No
For Single-Use:	Yes
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?
56710	Acetabulum prosthesis hole plug	A sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 4cc64109-b472-4b4a-a620-47e341a6922b
Public Version Date: May 12, 2023
Public Version Number: 8
DI Record Publish Date: January 01, 2017