FDA.reportPublic FDA data

BALLARD™

Primary DI
10889483565599
Brand
BALLARD™
Company
SUNMED, LLC
Model
99791
Catalog number
99791
Device description
BALLARD™ ORAL CARE TOOTHBRUSH PACK WITH ANTIPLAQUE SOLUTION
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483565596PackageGS110In Commercial Distribution
30889483565593PackageGS14In Commercial Distribution
00609038997919PreviousGS10
10889483565599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088948356559620889483565596
3088948356559330889483565593
00609038997919006090389979196090389979190609038997919
1088948356559910889483565599

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
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Premarket exempt
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
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15
10889483033289SunMed9-0210-019-0210-012024-03-12
10889483564578BALLARD™221036-5227036-52025-11-21
10889483040218SunMed5-0236-315-0236-312023-03-21
10889483221150AirLife™093709372025-12-18
10889483221181Vital Signs™8809-W8809-W2025-12-23
10889483221747AirLife™026202622025-12-19
10889483222027Co2 Easy5621342026-03-31
10889483222034Pedi Co2 Easy5621352026-03-31
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483222393AirLife™056205622025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942008099GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
00070942006378GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
00070942008105GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
00070942008112GUM Technique Deep CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
10810063756243KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756250Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756267Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756274Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756281Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756403Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756434KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756588Jr Series Comfort Grip ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756595Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756175Euro Tech Compact Sensitive ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756205Endeavor ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756212Vital Fresh ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756229Aspire Compact ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756236PlaquePRO Interdental Proxy BrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756397Polisher Compact ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756533Soft Flex ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756540Glisten Junior ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756557Curve Contour ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756564Silhouette ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756571Glisten Adult ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756618Value ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756625Nano Silver Care ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18