ZuriMED Technologies AG

GUDID 07649988202247

ZuriMED Technologies AG - FiberLocker Instrument SN

ZuriMED Technologies AG

Surgical support tape, non-bioabsorbable

• Primary Device ID: 07649988202247
• NIH Device Record Key: d0ef8dba-8434-4dfb-b525-c6be2d0d3596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZuriMED Technologies AG
• Version Model Number: FL516SNA
• Company DUNS: 480096456
• Company Name: ZuriMED Technologies AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07649988202247 [Primary]
GS1	17649988202244 [Package]; Package: Box [11 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241219

FDA Product Code

• OWX: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

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: 2025-02-18
• Device Publish Date: 2025-02-10

On-Brand Devices [ ZuriMED Technologies AG]

• 07649988202247: ZuriMED Technologies AG - FiberLocker Instrument SN
• 07649988202230: ZuriMED Technologies AG - FiberLocker Implant (SpeedPatch PET)