ELITE 252200502

GUDID 10603295128298

ELITE STEM INTRODUCER

DEPUY INTERNATIONAL LTD

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10603295128298
• NIH Device Record Key: 1ed3d4fb-5bfa-43a9-960c-fbf95650c493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE
• Version Model Number: 2522-00-502
• Catalog Number: 252200502
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295128298 [Primary]

FDA Product Code

• HWR: DRIVER, PROSTHESIS

Sterilization

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

[10603295128298]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-24

On-Brand Devices [ELITE]

• 10603295128298: ELITE STEM INTRODUCER
• 10603295318088: ELITE CUP OGEE - CEMENTED LPW 32mmID 53mmOD
• 10603295318071: ELITE CUP OGEE - CEMENTED LPW 32mmID 50mmOD
• 10603295318064: ELITE CUP OGEE - CEMENTED LPW 32mmID 47mmOD
• 10603295243397: ELITE FEMORAL PROS HOLDER
• 10603295243380: ELITE SOCKET GAUGE FOR 53MM CUP
• 10603295243366: ELITE SOCKET GAUGE FOR 50MM CUP
• 10603295243342: ELITE SOCKET GAUGE FOR 47MM CUP