PINNACLE Hip Solutions 121860051

GUDID 10603295520313

PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 60/51 60mm 51/28

DEPUY (IRELAND)

Metallic acetabular liner

• Primary Device ID: 10603295520313
• NIH Device Record Key: 97b43e1f-2b1c-411e-9cfc-ac3cf6f4fa9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINNACLE Hip Solutions
• Version Model Number: 1218-60-051
• Catalog Number: 121860051
• 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
• 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
• 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	10603295520313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200854

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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