DEVICE: Cervical Rasp (B114211000)

Device Identifier (DI) Information

Cervical Rasp
Cervical Rasp
In Commercial Distribution
211-00
CALVARY SPINE, LLC
B114211000
HIBCC

1
832116532 *Terms of Use
Bone Rasp used for site prep for cervical inter-vertebral body spacers
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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
Bone rasp A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LXH Orthopedic Manual Surgical Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

c83c854a-a382-4d59-9590-8d0edbad308a
March 29, 2018
2
March 01, 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

[?]
786-301-8006
james.r.edw@gmail.com
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