DEVICE: ORTHO SOLUTIONS STERILE DRILL BITS (05055662931365)
Device Identifier (DI) Information
ORTHO SOLUTIONS STERILE DRILL BITS
OS200145L
In Commercial Distribution
OS200145L
ORTHO SOLUTIONS HOLDINGS LIMITED
OS200145L
In Commercial Distribution
OS200145L
ORTHO SOLUTIONS HOLDINGS LIMITED
AO QC DRILL BIT 4.5/195/170
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? |
---|---|---|---|---|
47563 | Fluted surgical drill bit, single-use, non-sterile |
A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.
|
Obsolete | 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
b361c87b-63f1-49fd-b06e-a4bfc2fe09b6
November 22, 2018
4
January 20, 2017
November 22, 2018
4
January 20, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05055662931358 | 10 | 05055662931365 | 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