DIGITALIS Spacer DDG3T01001

GUDID 08057717554519

BRM EXTREMITIES SRL

Metacarpophalangeal joint prosthesis, one-piece

• Primary Device ID: 08057717554519
• NIH Device Record Key: 7e7589a6-a3df-4942-ab2c-f2a9f279d1cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGITALIS Spacer
• Version Model Number: MCP – SIZE 1
• Catalog Number: DDG3T01001
• Company DUNS: 435126746
• Company Name: BRM EXTREMITIES SRL
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com
• Phone: +3903411693087
• Email: info@brm-extremities.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057717554519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220142

FDA Product Code

• KYJ: Prosthesis, Finger, Constrained, Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-21
• Device Publish Date: 2024-05-13

On-Brand Devices [DIGITALIS Spacer]

• 08057717554595: PIP – SIZE 4
• 08057717554588: PIP – SIZE 3
• 08057717554571: PIP – SIZE 2
• 08057717554564: PIP – SIZE 1
• 08057717554557: MCP – SIZE 5
• 08057717554540: MCP – SIZE 4
• 08057717554533: MCP – SIZE 3
• 08057717554526: MCP – SIZE 2
• 08057717554519: MCP – SIZE 1