AccessGUDID - DEVICE: Revision Femoral Head (08033390183666)

GUDID

Device Identifier (DI) Information

Brand Name: Revision Femoral Head
Version or Model: 5010.42.052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5010.42.052
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390183666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: Revision Femoral Head - Dia.40 mm M Taper 12/14

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
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243809	000

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: Dia.40 mm M Taper 12/14

Device Record Status

Public Device Record Key: e2cc24e4-0537-48fe-b258-6f73f12297b5
Public Version Date: April 23, 2025
Public Version Number: 1
DI Record Publish Date: April 15, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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