FDA.reportPublic FDA data

Toothette Oral Care

Primary DI
00618029821171
Brand
Toothette Oral Care
Company
SAGE PRODUCTS, LLC
Model
6576
Catalog number
6576
Device description
Untreated Suction Toothbrush, Suction Swab, and Applicator Swab
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
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE
NSBPatient personal hygiene kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029821176PackageGS1100In Commercial Distribution
00618029821171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802982117650618029821176
00618029821171006180298211716180298211710618029821171

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable 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
Lot or batch
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
00850088713787PRINCETONPrinceton Medical Group, Inc.JOL2026-09-22
10809160536797HalyardMEDICAL ACTION INDUSTRIES INC.NSB2026-09-18
10809160537527HalyardMEDICAL ACTION INDUSTRIES INC.NSB2026-09-18
00190776423803MillenniumAvalign Technologies, Inc.JOL2026-08-26
04250603753148LAZICPeter Lazic GmbHJOL2026-08-25
04250603753155LAZICPeter Lazic GmbHJOL2026-08-25
04250603753162LAZICPeter Lazic GmbHJOL2026-08-25
04250603753179LAZICPeter Lazic GmbHJOL2026-08-25
04250603753186LAZICPeter Lazic GmbHJOL2026-08-25
04250603753193LAZICPeter Lazic GmbHJOL2026-08-25
00190776408695MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776408725MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776422813MillenniumAvalign Technologies, Inc.JOL2026-08-03
10609576801294Hospital®Puritan Medical ProductsKXF2026-07-31
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
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B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23