Silktoe Spacer BRDNEWP3535L

GUDID 08057717550849

BRM EXTREMITIES SRL

Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 08057717550849
• NIH Device Record Key: 2a9220b6-93cd-40ea-a582-57aee862bb1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silktoe Spacer
• Version Model Number: SIZE 35 LEFT
• Catalog Number: BRDNEWP3535L
• 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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 *Special Storage Condition, Specify: 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	08057717550849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191966

FDA Product Code

• KWH: Prosthesis, Toe, 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: 2021-10-25
• Device Publish Date: 2021-10-17

On-Brand Devices [Silktoe Spacer]

• 08057717550894: SIZE 50 RIGHT
• 08057717550887: SIZE 50 LEFT
• 08057717550870: SIZE 40 RIGHT
• 08057717550863: SIZE 40 LEFT
• 08057717550856: SIZE 35 RIGHT
• 08057717550849: SIZE 35 LEFT
• 08057717550832: SIZE 30 RIGHT
• 08057717550825: SIZE 30 LEFT
• 08057717550818: SIZE 20 RIGHT
• 08057717550801: SIZE 20 LEFT