DEVICE: Malibu (10889981082673)
Device Identifier (DI) Information
Malibu
91-7111
In Commercial Distribution
91-7111
SEASPINE ORTHOPEDICS CORPORATION
91-7111
In Commercial Distribution
91-7111
SEASPINE ORTHOPEDICS CORPORATION
Pedicle Finder
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
33433 | ENT probe, reusable |
A slender, rod-like, hand-held manual surgical instrument, typically with a blunt bulbous or pointed tip, used for exploring fistulas, cavities or wounds used during ear/nose/throat (ENT) intervention. The distal end of the instrument, before the bulb/point, may be bent at a right angle to the shaft. This is a reusable device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HXB | PROBE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
34c72d81-1e54-475e-8d2f-a9f1a6b5a8f8
March 21, 2019
4
May 02, 2016
March 21, 2019
4
May 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(760)727-8399
custsvcspine@seaspine.com
custsvcspine@seaspine.com