DEVICE: Shikani Antrostomy Stent (00385640000192)

Device Identifier (DI) Information

Shikani Antrostomy Stent
SP-80030
In Commercial Distribution
SP-80030
SUMMIT MEDICAL, INC.
00385640000192
GS1

1
965484699 *Terms of Use
No description.
CLOSE

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 cavity stent A non-sterile tubular device designed to be temporarily placed in the nasal cavity to improve nasal patency by splinting the nasal alar, valve and/or turbinates, typically in cases of collapse or hyperplasia. It consists of a self-expanding mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)], and is intended to be self-introduced through a nostril; devices associated with insertion and cleaning of the device may be included. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LYA Splint, Intranasal Septal
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

049524ab-b1e9-43b4-bcc9-95e901d3d985
April 25, 2018
3
August 09, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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