DEVICE: ActivaScrew™ (E302BALC45709)

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Device Identifier (DI) Information

ActivaScrew™
B-ALC-4570
B-ALC-4570
Bioretec Oy
E302BALC45709
HIBCC
1
ActivaScrew™ Cannulated LAG 4.5x70 mm, thread 32 mm
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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 screw, bioabsorbable A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.
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FDA Product Code

[?]
Product Code Product Code Name
HWC Screw, Fixation, Bone
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Sterilization

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

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

[?]
Size Type Text
Width: 4.5 Millimeter
Length: 70 Millimeter
Device Size Text, specify: Thread length 32 Millimeter
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Device Status

In Commercial Distribution
August 25, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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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