Straight Broach Handle 9095.11.011

GUDID 08033390104203

Straight Broach Handle M2 Connection for DAA

LIMACORPORATE SPA

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 08033390104203
• NIH Device Record Key: efc42896-dee0-49a2-8537-f90af5ff8c6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Broach Handle
• Version Model Number: Broach Handle
• Catalog Number: 9095.11.011
• 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	08033390104203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140975

FDA Product Code

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

Sterilization

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

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

[08033390104203]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-08-01
• Device Publish Date: 2017-06-22

On-Brand Devices [Straight Broach Handle]

• 08033390104203: Straight Broach Handle M2 Connection for DAA
• 08033390098311: Straight Broach Handle M2 Connection