FDA.reportPublic FDA data

Sage Self Oral Care

Primary DI
00618029831194
Brand
Sage Self Oral Care
Company
SAGE PRODUCTS, LLC
Model
6302
Catalog number
6302
Device description
Toothbrush with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse
Published
2019-08-12
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
EFWTOOTHBRUSH, MANUAL
JOLCATHETER AND TIP, SUCTION
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
JOLCatheter And Tip, SuctionGeneral Hospital2
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029831199PackageGS124In Commercial Distribution
00618029831194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802983119950618029831199
00618029831194006180298311946180298311940618029831194

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. 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
00618029980052Sage Fecal Management System700-118700-1182021-10-15
00618029980274Stryker Fecal Management System700-128700-1282023-03-07
00618029830128Q-Care Rx6904-PS6904-PS2023-09-07
00618029810328Toothette Oral Care400040002016-09-24
00618029830081Q-Care690469042016-09-24
00618029830166Q-Care691269122016-09-24
00618029830173Q-Care691469142016-09-24
00618029830753Q-Care696469642016-09-24
00618029830760Q-Care696269622016-09-24
00618029830975Q-Care697469742019-07-10
00618029831125Q-Care699269922018-12-10
00618029831149Q-Care Rx698269822018-12-10
00618029831118Q-Care906290622018-08-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002606616OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606623OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606630OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606647OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606654OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606661OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606678OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606685OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606692OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606708OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606715OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606722OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606739OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606746OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606753OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606760OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606777OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606784OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606791OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606807OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606814OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606821OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002613553CookCOOK INCORPORATEDJOL2026-10-22
00190776436384MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436391MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436407MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436414MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436421MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436469MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436476MilleniumAvalign Technologies, Inc.JOL2026-10-08