DEVICE: Piccolo Composite Nailing System (07290109339702)
Device Identifier (DI) Information
Piccolo Composite Nailing System
Radiographic Ruler
In Commercial Distribution
Q9105000
CARBOFIX ORTHOPEDICS LTD
Radiographic Ruler
In Commercial Distribution
Q9105000
CARBOFIX ORTHOPEDICS LTD
Ruler for use with the Piccolo Composite Humeral Nailing Systems.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45405 | Orthopaedic x-ray ruler |
A device used in an orthopaedic clinical setting to establish an accurate measurement of length or size related to a bone structure (i.e., length, thickness, or other aspects) when this is being viewed by the surgeon during fluoroscopy. It is a smooth-edged strip, typically made of stainless steel, that is marked in units of length (i.e., inches and/or millimetres) and includes a series of notches and holes that clearly show up on the x-ray image demonstrating the distances of the viewed bone. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | Rod, Fixation, Intramedullary And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091425 | 000 |
K100497 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
af760f44-9fc4-4d13-b232-cc774c0e7863
July 06, 2018
3
September 18, 2016
July 06, 2018
3
September 18, 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 |
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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
[?]
+97299511511
info@carbo-fix.com 1-800-408-0120
usa@carbo-fix.com
info@carbo-fix.com 1-800-408-0120
usa@carbo-fix.com