DEVICE: ActivaPin™ (E302BAP20309)

Device Identifier (DI) Information

ActivaPin™
B-AP-2030
In Commercial Distribution
B-AP-2030
Bioretec Oy
E302BAP20309
HIBCC

1
368715301 *Terms of Use
ActivaPin™ 2.0 mm x 30 mm
CLOSE

Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic bone pin, bioabsorbable A device in the form of a small diameter rod 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HTY Pin, Fixation, Smooth
CLOSE

FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Width: 2.0 Millimeter
Length: 30 Millimeter
CLOSE

Device Record Status

1dbe5165-d903-4b4f-a453-bbe3103e21b0
July 06, 2018
3
August 25, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+358207789500
sales@bioretec.com
CLOSE