FDA.reportPublic FDA data

Angled Toothbrush

Primary DI
10848956009541
Brand
Angled Toothbrush
Company
HEALTHMARK INDUSTRIES CO., INC.
Model
3184-10
Catalog number
3184-10
Published
2024-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848956009541PrimaryGS10
00848956009544Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084895600954110848956009541
00848956009544008489560095448489560095440848956009544

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Regulatory Flags#

DUNS number
057680480
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848956021263Sanizyme60030008332026-05-22
00848956021287Sanizyme60030008352026-05-22
00848956021294Sanizyme60030008362026-05-22
00848956021317Sanizyme60030008342026-05-22
10848956020010SAFEGUARD PROSGP112SGP1122025-10-20
10848956020027SAFEGUARD PROSGP115SGP1152025-10-20
10848956020034SAFEGUARD PROSGP1182025-10-20
10848956020041SAFEGUARD PROSGP124SGP1242025-10-20
10848956020058SAFEGUARD PROSGP130SGP1302025-10-20
10848956020065SAFEGUARD PROSGP136 SGP136 2025-10-20
10848956020072SAFEGUARD PROSGP212 SGP212 2025-10-20
10848956020089SAFEGUARD PROSGP218SGP2182025-10-20
10848956020096SAFEGUARD PROSGP224SGP2242025-10-20
10848956020102SAFEGUARD PROSGP230 SGP230 2025-10-20
10848956020119SAFEGUARD PROSGP236 SGP236 2025-10-20
10848956020126SAFEGUARD PROSGP324SGP3242025-10-20
10848956020133SAFEGUARD PROSGP330SGP3302025-10-20
10848956020140SAFEGUARD PROSGP336 SGP336 2025-10-20
10848956020157SAFEGUARD PROSGP345SGP3452025-10-20
10848956020164SAFEGUARD PROSGP354 SGP354 2025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810929045668Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045675Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045682Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045699Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045705Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045712Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045729Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045736Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
01081092904567Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045665Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045689Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045696Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045702Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045719Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045726Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045733Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
006664161214969000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
006664161220119000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24