FDA.reportPublic FDA data

Endoscope Brushes

Primary DI
00848956005348
Brand
Endoscope Brushes
Company
HEALTHMARK INDUSTRIES CO., INC.
Model
CC2-200-200-LV11
Catalog number
CC2-200-200-LV11
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10848956005345PrimaryGS10
00848956005348Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084895600534510848956005345
00848956005348008489560053488489560053480848956005348

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057680480
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
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
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
09421028490412PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490429PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490436PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490443PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490535PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-11-10
09421028490153PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490566PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490580PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490764PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028493079PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028493116PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-26
09421028490399PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-24
09421028490320PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-12
09421028493154PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-12
09421028490221PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028490788PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028491211PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10