ActivaNail™ B-ANCO-1520

GUDID E302BANCO15209

ActivaNail™ Conical 1.5 mm x 20 mm

Bioretec Oy

Orthopaedic bone pin, bioabsorbable

• Primary Device ID: E302BANCO15209
• NIH Device Record Key: 2174af1a-d822-49c4-b9d8-f856184fc38f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaNail™
• Version Model Number: B-ANCO-1520
• Catalog Number: B-ANCO-1520
• Company DUNS: 368715301
• Company Name: Bioretec Oy
• 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

Customer Support Contacts

• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com

Device Dimensions

• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter
• Length: 20 Millimeter
• Width: 1.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BANCO15209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080879

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-25

On-Brand Devices [ActivaNail™]

• E302BANCO20609: ActivaNail™ Conical 2.0 mm x 60 mm
• E302BANCO20309: ActivaNail™ Conical 2.0 mm x 30 mm
• E302BANCO20259: ActivaNail™ Conical 2.0 mm x 25 mm
• E302BANCO20209: ActivaNail™ Conical 2.0 mm x 20 mm
• E302BANCO20159: ActivaNail™ Conical 2.0 mm x 15 mm
• E302BANCO15609: ActivaNail™ Conical 1.5 mm x 60 mm
• E302BANCO15309: ActivaNail™ Conical 1.5 mm x 30 mm
• E302BANCO15259: ActivaNail™ Conical 1.5 mm x 25 mm
• E302BANCO15209: ActivaNail™ Conical 1.5 mm x 20 mm
• E302BANCO15159: ActivaNail™ Conical 1.5 mm x 15 mm
• E302BANCO15109: ActivaNail™ Conical 1.5 mm x 10 mm