DEVICE: Piccolo Composite Nailing System (07290109338194)

Device Identifier (DI) Information

Piccolo Composite Nailing System
Screwdriver - Short
In Commercial Distribution
PFT912360
CARBOFIX ORTHOPEDICS LTD
07290109338194
GS1

1
649185170 *Terms of Use
Screwdriver for use with the Piccolo Composite Tibia, Femur, Proximal Femur, and Ankle Arthrodesis Nailing Systems.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical screwdriver, reusable A non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. Some types may include a torque-measuring gauge. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102369 000
K111056 000
K123810 000
K151010 000
K153536 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

75714f04-59d2-437e-825b-dcf06355fd2c
July 24, 2018
4
September 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+97299511511
info@carbo-fix.com
1-800-408-0120
usa@carbo-fix.com
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