DIGITALIS INSTRUMENTS KIT KIT.DIGITALIS

GUDID 08053782781645

Instruments kit for the implant of BRM Extremities Digitalis device

BRM EXTREMITIES SRL

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08053782781645
• NIH Device Record Key: 62134a90-b1c3-4661-9d53-525419f56534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGITALIS INSTRUMENTS KIT
• Version Model Number: KIT.DIGITALIS
• Catalog Number: KIT.DIGITALIS
• Company DUNS: 435126746
• Company Name: BRM EXTREMITIES SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	08053782781645 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

[08053782781645]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-09
• Device Publish Date: 2024-11-29

Devices Manufactured by BRM EXTREMITIES SRL

• 08053782780488 - BRM TOOL SCREWS INSTRUMENT: 2025-04-15
• 08053782780495 - BRM TOOL SCREWS INSTRUMENT: 2025-04-15
• 08053782780501 - BRM TOOL SCREWS INSTRUMENT: 2025-04-15
• 08053782780129 - BRM TOOL SCREWS INSTRUMENT: 2025-04-14
• 08053782780136 - BRM TOOL SCREWS INSTRUMENT: 2025-04-14
• 08053782780143 - BRM TOOL SCREWS INSTRUMENT: 2025-04-14
• 08053782780235 - BRM TOOL SCREWS INSTRUMENT: 2025-04-14
• 08053782780259 - BRM TOOL SCREWS INSTRUMENT: 2025-04-14