AccessGUDID - DEVICE: Delta Dual Mobility System (08033390086325)

GUDID

Device Identifier (DI) Information

Brand Name: Delta Dual Mobility System
Version or Model: 5566.50.401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5566.50.401
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390086325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: Mobile Liner Dia. 40 mm for Head Dia. 28 mm

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?
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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: Dia. 40 mm for Head Dia. 28 mm

Device Record Status

Public Device Record Key: 36a88aa9-f09e-4b1f-b453-093ed2dbed95
Public Version Date: October 14, 2024
Public Version Number: 2
DI Record Publish Date: June 25, 2019