FDA.reportPublic FDA data

PULL THRU™ Cleaning Brush

Primary DI
09421028490221
Brand
PULL THRU™ Cleaning Brush
Company
F.R.GALANTAI MANUFACTURING COMPANY LIMITED
Model
ZZSB512+180 Double head port cleaning brush
Catalog number
ZZSB512+180
Device description
Port cleaning brush, double head, 5mm and 12mm.
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
09421028490221PrimaryGS10
09421028493451Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421028490221094210284902219421028490221
09421028493451094210284934519421028493451

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.

Contacts#

Phone, Email table
PhoneEmail
+648189558info@pullthru.net.nz

Regulatory Flags#

DUNS number
591592316
Device count
180
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421028490412PULL THRU™ Cleaning BrushCSD0305+6+0+610/80 - CSSD Instrument cleaning brusCSD0305+6+0+610/802022-11-10
09421028490429PULL THRU™ Cleaning BrushCSD0608+6+0+610/27 - CSSD Instrument cleaning brusCSD0608+6+0+610/272022-11-10
09421028490436PULL THRU™ Cleaning BrushCSD0912+6+0+610/09 - CSSD Instrument cleaning brusCSD0912+6+0+610/092022-11-10
09421028490443PULL THRU™ Cleaning BrushCSD1315+6+0+610/96 - CSSD Instrument cleaning brusCSD1315+6+0+610/962022-11-10
09421028490535PULL THRU™ Cleaning BrushCSD1426+1+0+610/40 - CSSD Instrument cleaning brusCSD1426+1+0+610/402022-11-10
09421028493482PULL THRU™ Cleaning BrushCSD0305+6+0+610/80 - CSSD Instrument cleaning brusCSD0305+6+0+610/802022-11-10
09421028493499PULL THRU™ Cleaning BrushCSD0608+6+0+610/27 - CSSD Instrument cleaning brusCSD0608+6+0+610/272022-11-10
09421028493505PULL THRU™ Cleaning BrushCSD0912+6+0+610/09 - CSSD Instrument cleaning brusCSD0912+6+0+610/092022-11-10
09421028493512PULL THRU™ Cleaning BrushCSD1315+6+0+610/96 - CSSD Instrument cleaning brusCSD1315+6+0+610/962022-11-10
09421028493475PULL THRU™ Cleaning BrushCSD1426+1+0+610/40 - CSSD Instrument cleaning brusCSD1426+1+0+610/402022-11-10
09421028490153PULL THRU™ Cleaning BrushZZ1426+180+0+2200 Refill packZZ1426+180+0+22002022-10-26
09421028490566PULL THRU™ Cleaning BrushZZ0112+180+0+2200 Refill packZZ0112+180+0+22002022-10-26
09421028490580PULL THRU™ Cleaning BrushZZ0112+60+0+2200 Refill packZZ0112+60+0+22002022-10-26
09421028490764PULL THRU™ Cleaning BrushZZ1426+60+0+2200 Refill packZZ1426+60+0+22002022-10-26
09421028493079PULL THRU™ Cleaning BrushZZ1426+60+NC+2200 - Refill pack plus dispenser casZZ1426+60+NC+22002022-10-26
09421028493116PULL THRU™ Cleaning BrushZZ0112+60+NC+2200 - Refill pack plus dispenser casZZ0112+60+NC+22002022-10-26
09421028490672PULL THRU™ Cleaning BrushZZ0112+1+SPUP+2200 Single patient packZZ0112+1+SPUP+22002022-10-26
09421028491594PULL THRU™ Cleaning BrushZZ1426+1+SPUP+2200 Single patient packZZ1426+1+SPUP+22002022-10-26
09421028492973PULL THRU™ Cleaning BrushCSD0112+6+0+610/75 - CSSD Instrument cleaning brusCSD0112+6+0+610/752022-10-26
09421028493437PULL THRU™ Cleaning BrushZZ1426+60+NC+2200 - Refill pack plus dispenser casZZ1426+60+NC+22002022-10-26

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
09421028490788PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028491211PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
10724995002173VERIFYSTERIS CORPORATIONMNL2021-03-31