DEVICE: Piccolo Composite Plate System (07290110200738)

Device Identifier (DI) Information

Piccolo Composite Plate System
Hohmann Retractor - Narrow
In Commercial Distribution
PL921808
CARBOFIX ORTHOPEDICS LTD
07290110200738
GS1

1
649185170 *Terms of Use
Retractor for use with the Piccolo Composite Distal Radius Plate Systems
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Orthopaedic retractor A hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HRS Plate, Fixation, Bone
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

97902e61-2d38-498c-8dda-f1c9ce63b5e3
March 29, 2018
2
October 10, 2016
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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
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Secondary DI

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

[?]
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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