DEVICE: Piccolo Composite Nailing System (07290109339139)
Device Identifier (DI) Information
Piccolo Composite Nailing System
Awl
In Commercial Distribution
PFT917000
CARBOFIX ORTHOPEDICS LTD
Awl
In Commercial Distribution
PFT917000
CARBOFIX ORTHOPEDICS LTD
Awl for use with the Piccolo Composite Tibia, Femur and Ankle Arthrodesis 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? |
---|---|---|---|---|
15275 | Bone awl, reusable |
A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. 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 [?] |
---|---|
K102369 | 000 |
K111056 | 000 |
K123810 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 13 Millimeter |
Device Record Status
2f8e8bdf-c5ac-470e-91d3-29f74fbdc148
June 10, 2022
4
September 18, 2016
June 10, 2022
4
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 |
---|---|
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