FDA.reportPublic FDA data

Sage Self Oral Care

Primary DI
00618029831200
Brand
Sage Self Oral Care
Company
SAGE PRODUCTS, LLC
Model
6304
Catalog number
6304
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
50618029831205PackageGS112In Commercial Distribution
00618029831200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802983120550618029831205
00618029831200006180298312006180298312000618029831200

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776423803MillenniumAvalign Technologies, Inc.JOL2026-08-26
04250603753148LAZICPeter Lazic GmbHJOL2026-08-25
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04250603753179LAZICPeter Lazic GmbHJOL2026-08-25
04250603753186LAZICPeter Lazic GmbHJOL2026-08-25
04250603753193LAZICPeter Lazic GmbHJOL2026-08-25
00190776408695MillenniumAvalign Technologies, Inc.JOL2026-08-03
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