DEVICE: ActivaPin™ (E302BAP15509)

Device Identifier (DI) Information

ActivaPin™
B-AP-1550
In Commercial Distribution
B-AP-1550
Bioretec Oy
E302BAP15509
HIBCC

1
368715301 *Terms of Use
ActivaPin™ 1.5 mm x 50 mm
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45037 Orthopaedic bone pin, bioabsorbable
A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HTY Pin, Fixation, Smooth
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K080879 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Length: 50 Millimeter
Width: 1.5 Millimeter
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Device Record Status

b82177a4-c326-4d15-92f3-68d60a22b15e
September 18, 2023
4
August 25, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+358207789500
sales@bioretec.com
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