AccessGUDID - DEVICE: Biolox® Option (04038653462636)

GUDID

Device Identifier (DI) Information

Brand Name: Biolox® Option
Version or Model: NJ435T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NJ435T
Company Name: Aesculap AG

Primary DI Number: 04038653462636
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: SLEEVE 8/10 S F/BIOLOX REVISION HEAD

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?
59688	Femoral head/stem prosthesis adaptor	A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.	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 : - 3.0
Device Size Text, specify: Taper Size : 8/10
Device Size Text, specify: Figure/Size : Size S

Device Record Status

Public Device Record Key: 074549ce-d977-469b-91a5-35c78fec029a
Public Version Date: November 13, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2015