9095.11.754

GUDID 08033390196123

AO Torque Wrench 2.5Nm

LIMACORPORATE SPA

Surgical instrument handle, torque-limiting

• Primary Device ID: 08033390196123
• NIH Device Record Key: ac86671f-6e4f-4e1d-b3c9-a3981b00c654
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 9095.11.754
• Catalog Number: 9095.11.754
• 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: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390196123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133349

FDA Product Code

• HRW: Dynamometer, Nonpowered
• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

[08033390196123]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-16
• Device Publish Date: 2022-09-08

Devices Manufactured by LIMACORPORATE SPA

• 08033390282642 - ProMade Shoulder: 2024-08-15 ProMade Shoulder - Long Helix Drill Dia. 3,5 mm
• 08033390282659 - ProMade Shoulder: 2024-08-15 ProMade Shoulder - Guide for Long Helix Drill Dia. 3,5 mm
• 08033390134415 - SMR Shoulder: 2024-08-06 SMR Shoulder - Removal Pliers
• 08033390080637 - SMR Shoulder: 2024-08-05 SMR Shoulder - Reverse liners 36mm (UHMWPE) +6mm
• 08033390085502 - NA: 2024-08-05 Curved Depth Gauge
• 08033390115667 - SMR TT Hybrid Glenoid: 2024-08-05 Hybrid Glenoid Baseplate Small LOW +4 - Peg L
• 08033390115698 - SMR TT Hybrid Glenoid: 2024-08-05 Hybrid Glenoid Baseplate Large LOW +4 - Peg S
• 08033390115711 - SMR TT Hybrid Glenoid: 2024-08-05 Hybrid Glenoid Baseplate Large LOW +4 - Peg L