DEVICE: ODI 7.0mm Cannulated Screw System (B058CSS0011371)

Device Identifier (DI) Information

ODI 7.0mm Cannulated Screw System
CSS001137
In Commercial Distribution

Orthopedic Designs North America, Inc.
B058CSS0011371
HIBCC

1
945518848 *Terms of Use
Washer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 bone washer, non-sterile A non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HTN Washer, Bolt Nut
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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

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Size Type Text
Outer Diameter: 13 Millimeter
Lumen/Inner Diameter: 7.2 Millimeter
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Device Record Status

1a890b92-a053-4e69-910d-f0ab1914e994
March 29, 2018
2
October 22, 2015
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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
Yes
No CLOSE

Customer Contact

[?]
888-635-8535
support@odi-na.com
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