DEVICE: Piccolo Composite Plate System (07290110200510)

Device Identifier (DI) Information

Piccolo Composite Plate System
Hohmann Retractor - Wide
In Commercial Distribution
PL921815
CARBOFIX ORTHOPEDICS LTD
07290110200510
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
Hand-held surgical retractor, reusable A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K102597 000
K160002 000
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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

58ec6d39-f17c-4ee1-8ee4-49bc1dd9dab3
July 06, 2018
4
September 22, 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

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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

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