DEVICE: ORTHO SOLUTIONS STERILE DRILL BITS (05055662932935)
Device Identifier (DI) Information
ORTHO SOLUTIONS STERILE DRILL BITS
OS319052
In Commercial Distribution
OS319052
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319052
In Commercial Distribution
OS319052
ORTHO SOLUTIONS HOLDINGS LIMITED
2.3MM PHALANGEAL SCREW CANNULATED DRILL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
61235 | Cannulated surgical drill bit, single-use |
A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K102743 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dcf9a273-103e-4a53-8c2f-76160ae8245d
November 28, 2022
6
February 02, 2016
November 28, 2022
6
February 02, 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 |
---|---|---|---|---|---|
05055662932942 | 10 | 05055662932935 | In Commercial Distribution | Cardboard Box |
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
[?]
+441621843599
quality@orthosol.com
quality@orthosol.com