FDA.report

Shikani Antrostomy Stent

Primary DI
00385640000178
Brand
Shikani Antrostomy Stent
Company
SUMMIT MEDICAL, INC.
Model
SP-80010
Catalog number
SP-80010
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYASplint, Intranasal Septal

Product Code Classifications

CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10385640000175PackageGS16In Commercial Distribution
00385640000178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564000017510385640000175
00385640000178003856400001783856400001780385640000178

GMDN Terms

TermDefinition
Nasal cavity stent, removable, prefabricatedA non-sterile, prefabricated (non-customized), tubular device designed to be temporarily placed in the nasal cavity to improve nasal patency, 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.

Sterilization Methods

Method

Contacts

PhoneEmail
888-229-2875customerservice@summitmedicalusa.com

Regulatory Flags

DUNS number
965484699
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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