Identity
- Trade Name
- Batrik Cautery Tip Cleaners FDA UDI
- Generic Name
- Electrosurgical tip cleaning pad FDA UDI
- Device Name
- NON-STERILE CAUTERY TIP CLEANERS EUDAMEDCautery Tip Cleaners, Non-sterile, 1.8" x 1.8" (4.5 cm x 4.5 cm) FDA UDI
- Model / Reference
- 60-10000 EUDAMEDFDA UDI
- Description
- Cautery Tip Cleaners, Non-sterile, 1.8" x 1.8" (4.5 cm x 4.5 cm) FDA UDI
Identifiers
- Catalog Number
- 60-10000 FDA UDI
- Primary DI / UDI-DI
- 00690521009332 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210CAUT1000KF EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- M03030203 FOAM PADS EUDAMED
- GMDN Term
- Electrosurgical tip cleaning pad FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Non-Sterile Cautery Tip Cleaners by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 6905210CAUT1000KF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED bb285e79-cb13-4dc3-9882-4263f7960049 61 fields · synced Jun 19, 2026
- FDA UDI bcc4769f-9a89-4484-9561-64036ea62484 36 fields · synced May 29, 2026