REVISION Hip 9038.10.250

GUDID 08033390046817

Trial Neck Extractor

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390046817
• NIH Device Record Key: 25b2d4d5-0b8d-46cb-9d7f-e149d5f233a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVISION Hip
• Version Model Number: Trial Neck Extractor
• Catalog Number: 9038.10.250
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390046817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151739

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

Moist Heat or Steam Sterilization

[08033390046817]

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: 2016-05-12

On-Brand Devices [REVISION Hip]

• 08033390112642: Neck Impactor Extractor
• 08033390046817: Trial Neck Extractor
• 08033390024174: Neck Impactor Extractor