DEVICE: 2.4 Cortex Screw, hex, tapping, St.Steel, L 34 mm (EMAH0010021034S0)
Device Identifier (DI) Information
2.4 Cortex Screw, hex, tapping, St.Steel, L 34 mm
001-0021-034S
In Commercial Distribution
001-0021-034S
mahe medical gmbh
001-0021-034S
In Commercial Distribution
001-0021-034S
mahe medical gmbh
2.4 Cortex Screw, hex, tapping,
St.Steel, L 34 mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
56642 | Orthopaedic bone screw, non-bioabsorbable, non-sterile |
A small, non-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 cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: cool, dry & dark place |
Storage Environment Humidity: between 10 and 50 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 28 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 2.4 Millimeter |
Length: 34.0 Millimeter |
Device Record Status
45bd498a-9166-4e83-9c37-8e75341f1c13
February 19, 2024
3
August 01, 2016
February 19, 2024
3
August 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EMAH0010021034S1 | 1 | EMAH0010021034S0 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49(0)746592750
info@mahe-med.de
info@mahe-med.de