DEVICE: ORTHO SOLUTIONS STERILE DRILL BITS (05055662929065)

Device Identifier (DI) Information

ORTHO SOLUTIONS STERILE DRILL BITS
OS307104
In Commercial Distribution
OS307104
ORTHO SOLUTIONS HOLDINGS LIMITED
05055662929065
GS1

1
218648211 *Terms of Use
METATARSAL REAMER, LARGE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Medullary canal orthopaedic reamer, rigid An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102743 000
No 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

b45de6dd-5923-4813-8985-10111107bfe6
July 06, 2018
3
April 20, 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

[?]
+441621843599
quality@orthosol.com
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