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 External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner External limb prosthesis socket liner 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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