AccessGUDID - DEVICE: BioBall DELTA™ Ceramic Head (04048266025456)

GUDID

Device Identifier (DI) Information

Brand Name: BioBall DELTA™ Ceramic Head
Version or Model: 28
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HM50028
Company Name: Merete GmbH

Primary DI Number: 04048266025456
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: ISO 6474-2 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?
38156	Ceramic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	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
Outer Diameter: 28 Millimeter

Device Record Status

Public Device Record Key: 8f1496f2-d98a-472a-a232-700e7955e593
Public Version Date: December 14, 2021
Public Version Number: 6
DI Record Publish Date: October 15, 2015