AccessGUDID - DEVICE: Biolox® delta (04046963511906)

GUDID

Device Identifier (DI) Information

Brand Name: Biolox® delta
Version or Model: NK461D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NK461D
Company Name: Aesculap AG

Primary DI Number: 04046963511906
Issuing Agency: GS1
Commercial Distribution End Date: January 22, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: BIOLOX DELTA PROSTH.HEAD 12/14 28MM M

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
Device Size Text, specify: Neck length : 0
Device Size Text, specify: Taper Size : 12/14
Device Size Text, specify: Outer diameter (mm) : 28.000 MM
Device Size Text, specify: Figure/Size : Size M

Device Record Status

Public Device Record Key: 0a5b7c18-39a8-451e-a720-355846f5685f
Public Version Date: November 17, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2015