FDA.reportPublic FDA data

RhinoCath Nasal Suction

Primary DI
00385640000093
Brand
RhinoCath Nasal Suction
Company
Summit Medical, Inc.
Model
SP-45000
Catalog number
SP-45000
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385640000090PackageGS15In Commercial Distribution
00385640000093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564000009010385640000090
00385640000093003856400000933856400000930385640000093

GMDN Terms#

Term, Definition table
TermDefinition
Nasal haemostatic catheterA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-229-2875customerservice@summitmedicalusa.com

Regulatory Flags#

DUNS number
965484699
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

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Primary DI, Brand, Company table
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