DEVICE: ORTHO SOLUTIONS STERILE DRILL BITS (05055662932928)
Device Identifier (DI) Information
ORTHO SOLUTIONS STERILE DRILL BITS
OS319050
In Commercial Distribution
OS319050
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319050
In Commercial Distribution
OS319050
ORTHO SOLUTIONS HOLDINGS LIMITED
2.3MM PHALANGEAL SCREW COUNTERSINK
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? |
---|---|---|---|---|
47634 | Surgical countersink, single-use |
A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.
|
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 |
---|
No Device Sizes |
Device Record Status
46306e82-ff5a-4724-9b61-99ac5291eb01
July 06, 2018
3
February 19, 2016
July 06, 2018
3
February 19, 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 |
---|---|---|---|---|---|
05055662932911 | 10 | 05055662932928 | 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