PHYSICA MIS 9065.20.A20

GUDID 08033390133685

Tibial Cutting Block 0° Right

LIMACORPORATE SPA

Orthopaedic reamer guide

• Primary Device ID: 08033390133685
• NIH Device Record Key: a95558bf-8a54-4e8b-bd41-e17c735c308e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA MIS
• Version Model Number: Tibial Cutting Block
• Catalog Number: 9065.20.A20
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390133685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

[08033390133685]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-05
• Device Publish Date: 2018-01-19

On-Brand Devices [PHYSICA MIS]

• 08033390133715: Tibial Cutting Block 3° Left
• 08033390133708: Tibial Cutting Block 0° Left
• 08033390133692: Tibial Cutting Block 3° Right
• 08033390133685: Tibial Cutting Block 0° Right
• 08033390133678: Femoral A/P Sizing Stylus
• 08033390133661: Femoral A/P Sizer