FDA.reportPublic FDA data

Toothette Oral Care

Primary DI
50618029800607
Brand
Toothette Oral Care
Company
SAGE PRODUCTS, LLC
Model
6502
Catalog number
6502
Device description
Q2 Oral Cleansing & Suctioning System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50618029800607PackageGS110In Commercial Distribution
00618029800602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5061802980060750618029800607
00618029800602006180298006026180298006020618029800602

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-cleaning solutionA liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
054326178
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800492Adler Instrument CompanyAdler, Inc.JOL2026-07-17
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00846159040685SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17
10888277407954MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-07-17
04719874957568Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
04719874958503Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
00190776396794MillenniumAvalign Technologies, Inc.JOL2026-07-14
00888937033823ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033830ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033847ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033854ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033861ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00848530109110Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.JOL2026-06-10
10192253038927ArgyleCardinal Health 200, LLCJOL2026-05-07
10080196994137MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-27
10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
00840183530990BR Surgical, LLCBR Surgical, LLCJOL2025-09-05
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07