PULL THRU™ Cleaning Brush
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- PULL THRU™ Cleaning Brush EUDAMEDFDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- Port cleaning brush, double head, 5mm and 12mm. FDA UDI
- Model / Reference
- PULL THRU™ Cleaning Brush EUDAMEDZZSB512+180 EUDAMEDZZSB512+180 Double head port cleaning brush FDA UDI
- Description
- Port cleaning brush, double head, 5mm and 12mm. FDA UDI
Identifiers
- Catalog Number
- ZZSB512+180 FDA UDI
- Primary DI / UDI-DI
- 09421028490221 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102849MDCCB8G 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
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
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.
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- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102849MDCCB8G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- F R Galantai Manufacturing Company Limited
- EUDAMED SRN
- NZ-MF-000002767
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 3afdaea2-5a34-4250-b689-f75c1ef5c60b 61 fields · synced Jun 18, 2026
- FDA UDI 28e52101-6c0c-4367-b01e-073d0d861cc5 35 fields · synced May 29, 2026