ActivaPin™ B-AP-3250

GUDID E302BAP32509

ActivaPin™ 3.2 mm x 50 mm

Bioretec Oy

Orthopaedic bone pin, bioabsorbable

• Primary Device ID: E302BAP32509
• NIH Device Record Key: 44e4f02b-ecd0-4d7b-aa65-3ae67bd57121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaPin™
• Version Model Number: B-AP-3250
• Catalog Number: B-AP-3250
• 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

• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter
• Width: 3.2 Millimeter
• Length: 50 Millimeter

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BAP32509 [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 [ActivaPin™]

• E302BAP32709: ActivaPin™ 3.2 mm x 70 mm
• E302BAP32609: ActivaPin™ 3.2 mm x 60 mm
• E302BAP32509: ActivaPin™ 3.2 mm x 50 mm
• E302BAP32409: ActivaPin™ 3.2 mm x 40 mm
• E302BAP27709: ActivaPin™ 2.7 mm x 70 mm
• E302BAP27609: ActivaPin™ 2.7 mm x 60 mm
• E302BAP27509: ActivaPin™ 2.7 mm x 50 mm
• E302BAP27409: ActivaPin™ 2.7 mm x 40 mm
• E302BAP27309: ActivaPin™ 2.7 mm x 30 mm
• E302BAP20709: ActivaPin™ 2.0 mm x 70 mm
• E302BAP20609: ActivaPin™ 2.0 mm x 60 mm
• E302BAP20509: ActivaPin™ 2.0 mm x 50 mm
• E302BAP20409: ActivaPin™ 2.0 mm x 40 mm
• E302BAP20309: ActivaPin™ 2.0 mm x 30 mm
• E302BAP20209: ActivaPin™ 2.0 mm x 20 mm
• E302BAP15709: ActivaPin™ 1.5 mm x 70 mm
• E302BAP15609: ActivaPin™ 1.5 mm x 60 mm
• E302BAP15509: ActivaPin™ 1.5 mm x 50 mm
• E302BAP15409: ActivaPin™ 1.5 mm x 40 mm
• E302BAP15309: ActivaPin™ 1.5 mm x 30 mm
• E302BAP15209: ActivaPin™ 1.5 mm x 20 mm