ComfortSil.soft -6mm- 41L10/25

GUDID 04048817378857

ComfortSil.soft -6mm- silicone liner with distal connection, one-piece knit cover, 10 cm outer matrix, antibacterial finish

Streifeneder ortho.production GmbH

External limb prosthesis socket liner

• Primary Device ID: 04048817378857
• NIH Device Record Key: 5d019f8a-5392-4b5c-b083-8ff53cf1f77d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfortSil.soft -6mm-
• Version Model Number: 41L10/25
• Catalog Number: 41L10/25
• Company DUNS: 317931954
• Company Name: Streifeneder ortho.production GmbH
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048817378857 [Primary]

FDA Product Code

• ISS: Prosthesis, Thigh Socket, External Component

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-23
• Device Publish Date: 2020-10-15

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