DEVICE: Huestis Medical Flexi-Holder (00085007700701)

Device Identifier (DI) Information

Huestis Medical Flexi-Holder
FH303
Not in Commercial Distribution

HUESTIS MACHINE CORPORATION
00085007700701
GS1
December 05, 2016
1
001188390 *Terms of Use
Flexi-Holder 26" Short Arm, Huestis Part # FH303
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
X-ray film cassette holder A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).
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FDA Product Code

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Product Code Product Code Name
IXA Cassette, Radiographic Film
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K792721 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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

d7f1fe71-1b5d-4758-a782-5eafa21048d1
July 06, 2018
3
November 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

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No
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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