PINNACLE Hip Solutions 121852045

GUDID 10603295520276

PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 52/45 52mm 45/22.2

DEPUY (IRELAND)

Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner

• Primary Device ID: 10603295520276
• NIH Device Record Key: 638b9b58-7c0f-4f1b-9cb8-57fa4c659146
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINNACLE Hip Solutions
• Version Model Number: 1218-52-045
• Catalog Number: 121852045
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295520276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200854

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-12-11

On-Brand Devices [PINNACLE Hip Solutions]

• 10603295520344: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 66/55 66
• 10603295520337: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 64/53 64
• 10603295520320: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 62/53 62
• 10603295520313: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 60/51 60
• 10603295520306: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 58/49 58
• 10603295520290: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 56/49 56
• 10603295520283: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 54/47 54
• 10603295520276: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 52/45 52
• 10603295520184: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 50/43 50
• 10603295520177: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 48/41 48