DEVICE: RhinoCath Nasal Suction (00385640000093)

Device Identifier (DI) Information

RhinoCath Nasal Suction
SP-45000
In Commercial Distribution
SP-45000
SUMMIT MEDICAL, INC.
00385640000093
GS1

1
965484699 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Nasal haemostatic catheter A sterile nasal catheter designed to control nose bleeding (epistaxis). This device will usually consist of a single lumen tube with a sponge attached near its distal tip. It will typically include an integral airway that allows the patient to breath through the nose while the catheter is in place. Some designs consist of a double-lumen with a balloon attached to each distal end to be used simultaneously in both nasal cavities and can also be used to stabilize zygomatic arch fractures. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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FDA Premarket Submission

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

Sterilization

Yes
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

b95fa713-1b2d-4ee1-980e-2a1686debc3e
March 29, 2018
2
August 09, 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)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
888-229-2875
customerservice@summitmedicalusa.com
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