AccessGUDID - DEVICE: PINNACLE Hip Solutions (10603295520283)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE Hip Solutions
Version or Model: 1218-54-047
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 121854047
Company Name: DEPUY (IRELAND)

Primary DI Number: 10603295520283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989365556 *Terms of Use

Device Description: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 54/47 54mm 47/28

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
48056	Metallic acetabular liner	An implantable inner 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 metal [e.g., cobalt-chrome (Co-Cr)].	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
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

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
No Device Sizes

Device Record Status

Public Device Record Key: 17fbfd93-2129-4d8e-acce-0c60d9a39321
Public Version Date: September 26, 2024
Public Version Number: 2
DI Record Publish Date: December 11, 2020