Identity
- Trade Name
- SuperDART® ONE PASS™ ECCD Kit EUDAMEDSuperDART® ONE PASS™ Validated Channel Cleaning Kit FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- Disposable Cleaning Brushes for Flexible Endoscopes Reprocessing EUDAMEDKIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9253 + 9990). HIBC/UPN: M45393552 FDA UDI
- Model / Reference
- 9355-25 EUDAMED9355 FDA UDI
- Description
- KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9253 + 9990). HIBC/UPN: M45393552 FDA UDI
Identifiers
- Catalog Number
- 9355-25 FDA UDI
- Primary DI / UDI-DI
- 00666416121274 EUDAMEDFDA UDI
- Basic UDI-DI
- 666416DCBWT EUDAMED
- Secondary DI
- M45393552 EUDAMED
- Unit of Use DI
- 00666416121267 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070102 DIGESTIVE ENDOSCOPY ENDOSCOPES CLEANING BRUSHES 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
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
A comprehensive medical device directory containing information on the SuperDART ONE PASS ECCD Kit.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 666416DCBWT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PriMed Instruments Inc.
- EUDAMED SRN
- CA-MF-000002760
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED f8abb662-f161-4040-b002-143a54673d60 61 fields · synced Jul 10, 2026
- FDA UDI 61d61199-b558-4d2b-9636-b082c0ea6a96 36 fields · synced May 30, 2026