Bipolar Head 9050.10.201

GUDID 08033390112314

Trial Head Inserter

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390112314
• NIH Device Record Key: cb521ae5-a105-4da5-9f31-aab8fe1ab702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Head
• Version Model Number: Trial Head Inserter
• Catalog Number: 9050.10.201
• 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	08033390112314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

Moist Heat or Steam Sterilization

[08033390112314]

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: 2016-06-17

On-Brand Devices [Bipolar Head]

• 08033390112314: Trial Head Inserter
• 08033390032506: Trial Head Dia.54mm
• 08033390032490: Trial Head Dia.53mm
• 08033390032476: Trial Head Dia.52mm
• 08033390032469: Trial Head Dia.51mm
• 08033390032452: Trial Head Dia.50mm
• 08033390032445: Trial Head Dia.49mm
• 08033390032438: Trial Head Dia.48mm
• 08033390032414: Trial Head Dia.47mm
• 08033390032407: Trial Head Dia.46mm
• 08033390032391: Trial Head Dia.45mm