PINNACLE 221810028

GUDID 10603295457169

PINNACLE CERAMIC LINER INSERTER PUSHER 28mm

DEPUY (IRELAND)

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10603295457169
• NIH Device Record Key: cc898a4b-f45c-4db4-a466-b5f7d1064d58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINNACLE
• Version Model Number: 2218-10-028
• Catalog Number: 221810028
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295457169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070026

FDA Product Code

• HXO: PUSHER, SOCKET
• MRA: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Sterilization

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

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

[10603295457169]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-12-15

On-Brand Devices [PINNACLE]

• 10603295457411: PINNACLE CERAMIC LINER INSERTER PUSHER 36mm
• 10603295457404: PINNACLE CERAMIC LINER INSERTER PUSHER 32mm
• 10603295457282: PINNACLE CERAMIC LINER INSERTER GRIPPER 66mm
• 10603295457275: PINNACLE CERAMIC LINER INSERTER GRIPPER 64mm
• 10603295457268: PINNACLE CERAMIC LINER INSERTER GRIPPER 62mm
• 10603295457251: PINNACLE CERAMIC LINER INSERTER GRIPPER 60mm
• 10603295457244: PINNACLE CERAMIC LINER INSERTER GRIPPER 58mm
• 10603295457237: PINNACLE CERAMIC LINER INSERTER GRIPPER 56mm
• 10603295457220: PINNACLE CERAMIC LINER INSERTER GRIPPER 54mm
• 10603295457213: PINNACLE CERAMIC LINER INSERTER GRIPPER 52mm
• 10603295457206: PINNACLE CERAMIC LINER INSERTER GRIPPER 50mm
• 10603295457190: PINNACLE CERAMIC LINER INSERTER GRIPPER 48mm
• 10603295457183: PINNACLE CERAMIC LINER INSERTER GRIPPER 46mm
• 10603295457176: PINNACLE CERAMIC LINER INSERTER GRIPPER 44mm
• 10603295457169: PINNACLE CERAMIC LINER INSERTER PUSHER 28mm
• 10603295491385: PINNACLE CERAMIC LINER INSERTER TRAY INSERT
• 10603295457428: PINNACLE CERAMIC LINER INSERTER OUTER CASE
• 10603295432593: PINNACLE DRILL BIT CADDY
• 10603295424284: PINNACLE UTILITY CASE
• 10603295424277: PINNACLE BEARING REMOVAL CASE
• 10603295424260: PINNACLE REVISION EXTRA LARGE GRATER / TRIAL CASE
• 10603295424253: PINNACLE REVISION SHELL TRIAL CASE
• 10603295424246: PINNACLE LARGE POLY TRIAL CASE
• 10603295424239: PINNACLE LARGE GRATER / SHELL TRIAL CASE
• 10603295424222: PINNACLE ALTERNATIVE BEARING TRIAL CASE
• 10603295424215: PINNACLE BANTAM CASE
• 10603295424208: PINNACLE SCREW SET CASE
• 10603295424192: PINNACLE POLY TRIAL CASE
• 10603295424185: PINNACLE CORE CASE
• 10603295424178: PINNACLE GRATER HEAD CASE
• 10603295520795: PINNACLE DUAL MOBILITY TRAY
• 10603295520627: PINNACLE DUAL MOBILITY THREADED LINER EXTRACTOR
• 10603295520603: PINNACLE DUAL MOBILITY LINER TRIAL 66/55
• 10603295520597: PINNACLE DUAL MOBILITY LINER TRIAL 60/51
• 10603295520580: PINNACLE DUAL MOBILITY LINER TRIAL 58/49
• 10603295520573: PINNACLE DUAL MOBILITY LINER TRIAL 56/49
• 10603295520566: PINNACLE DUAL MOBILITY LINER TRIAL 54/47
• 10603295520559: PINNACLE DUAL MOBILITY LINER TRIAL 52/45
• 10603295520542: PINNACLE DUAL MOBILITY LINER TRIAL 64/53
• 10603295520535: PINNACLE DUAL MOBILITY LINER TRIAL 62/53
• 10603295520528: PINNACLE DUAL MOBILITY LINER TRIAL 50/43
• 10603295520511: PINNACLE DUAL MOBILITY LINER TRIAL 48/41
• 10603295520269: PINNACLE MOBILE BEARING HEAD TRIAL 55/28
• 10603295520252: PINNACLE MOBILE BEARING HEAD TRIAL 53/28
• 10603295520245: PINNACLE MOBILE BEARING HEAD TRIAL 51/28
• 10603295520238: PINNACLE MOBILE BEARING HEAD TRIAL 49/28
• 10603295520221: PINNACLE MOBILE BEARING HEAD TRIAL 47/28
• 10603295520214: PINNACLE MOBILE BEARING HEAD TRIAL 45/22.225
• 10603295520207: PINNACLE MOBILE BEARING HEAD TRIAL 43/22.225
• 10603295520191: PINNACLE MOBILE BEARING HEAD TRIAL 41/22.225