Rotium Bioresorbable Wick

GUDID 20852513007052

NANOFIBER SOLUTIONS, INC.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 20852513007052
• NIH Device Record Key: 94a003a2-e96e-496a-b040-f1ec8c5948d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotium Bioresorbable Wick
• Version Model Number: FG-0007
• Company DUNS: 830384223
• Company Name: NANOFIBER SOLUTIONS, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter
• Width: 2 Centimeter
• Length: 2 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852513007058 [Primary]
GS1	10852513007055 [Package]; Contains: 00852513007058; Package: Shelf Box [1 Units]; In Commercial Distribution
GS1	20852513007052 [Package]; Contains: 10852513007055; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183236

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2019-04-11
• Device Publish Date: 2019-04-03

On-Brand Devices [Rotium Bioresorbable Wick]

• 20852513007052: FG-0007
• 00852513007317: FG-0043