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PULL THRU™ Cleaning Brush

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ZZ1426+1+SPUP+2200Model Single Patient Use Pack

by F R Galantai Manufacturing Company Limited

Identity

Trade Name
PULL THRU™ Cleaning Brush EUDAMEDFDA UDI
Generic Name
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Device Name
1 x Channel cleaning brush, channel ID 1.4-2.6mm, length 2200mm, 3 x 360 degree wipers. 1 x Port cleaning brush, double head, 5mm and 12mm. FDA UDI
Model / Reference
Single Patient Use Pack EUDAMED
ZZ1426+1+SPUP+2200 EUDAMED
ZZ1426+1+SPUP+2200 Single patient pack FDA UDI
Description
1 x Channel cleaning brush, channel ID 1.4-2.6mm, length 2200mm, 3 x 360 degree wipers. 1 x Port cleaning brush, double head, 5mm and 12mm. FDA UDI

Identifiers

Catalog Number
ZZ1426+1+SPUP+2200 FDA UDI
Primary DI / UDI-DI
09421028491594 EUDAMEDFDA UDI
Basic UDI-DI
942102849MDCCBPPFU EUDAMED
FDA Product Code
MNL FDA UDI
EMDN Code
V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE EUDAMED
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
876.1500 FDA UDI
Medical Purpose
The contents of the procedure pack are single use brushes intended for the manual cleaning of endoscopes and other medical instruments which may have internal channels. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument/endoscope cleaning utensil, single-use

PULL THRU™ Cleaning Brush by F.r.galantai Manufacturing Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/endoscope cleaning utensil, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
F R Galantai Manufacturing Company Limited
EUDAMED SRN
NZ-PR-000034534

Sources (2)

  • EUDAMED 4ada12a3-ed68-4250-a773-4b5b3a979e20 61 fields · synced Jun 20, 2026
  • FDA UDI 500d81bc-678d-4d4f-b8b5-5dc337f39745 35 fields · synced May 29, 2026