FDA.reportPublic FDA data

Toothette Oral Care

Primary DI
00618029800640
Brand
Toothette Oral Care
Company
SAGE PRODUCTS, LLC
Model
6513
Catalog number
6513
Device description
Suction Swabs with Perox-A-Mint Solution and Mouth Moisturizer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029800645PackageGS1100In Commercial Distribution
00618029800640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802980064550618029800645
00618029800640006180298006406180298006400618029800640

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, single-useA collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-2220customer-service-spcl@sageproducts.com

Regulatory Flags#

DUNS number
054326178
Device count
1
Premarket exempt
true
Kit
true
Combination product
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
00618029831118Q-Care906290622018-08-10
00618029980274Stryker Fecal Management System700-128700-1282023-03-07
00618029720801Sage Air Tap LC728772872019-10-01
07613327680720Q-Care682268222025-12-03
07613327680737Q-Care694269422025-12-03
07613327680744Q-Care698469842025-12-03
07613327680751Q-Care682468242025-12-03
57613327680725Q-Care682268222025-12-03
57613327680732Q-Care694269422025-12-03
57613327680749Q-Care698469842025-12-03
57613327680756Q-Care682468242025-12-03
07613327632842Sage Multi-Position MATS 2.0323432342025-11-19
07613327632859Sage325032502025-11-19
07613327632866Sage325132512025-11-19
07613327672718Sage Multi-Position MATS 2.0323132312025-11-19
00618029720856Sage AirTAP LC728972892020-04-20
00618029760869Sage Multi-Position MATS323232322021-10-15
07613327632835Sage Multi-Position MATS323332332024-08-12
07613327632873Sage TAP LC728172812024-03-26
07613327632880Sage TAP LC728272822024-03-26

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