Identity
- Trade Name
- SURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELL FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- SURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELL FDA UDI
- Model / Reference
- CL-10402-04-10 FDA UDI
- Description
- SURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELL FDA UDI
Identifiers
- Catalog Number
- 26871 FDA UDI
- Primary DI / UDI-DI
- 00840828183383 FDA UDI
- 510(k) Number
- K080605 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic electrode, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Sure Lock, A34, 10 Pk, Blue, Philips/Curbell by Curbell Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K080605 also covers:
- SURE LOCK, A34, 10 PK, BLUE LEVER, MIDMARK — CURBELL MEDICAL PRODUCTS, INC.
- SURE LOCK, A34, 10 PK, BLUE, PHILIPS/CURBELL — CURBELL MEDICAL PRODUCTS, INC.
- SURE LOCK, A34, 10 PK, GRN LEVER, CAREFUSION — CURBELL MEDICAL PRODUCTS, INC.
- SURE LOCK, A34, 14 PK, GRN LEVER, CAREFUSION — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
- SURE-LOCK — CURBELL MEDICAL PRODUCTS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 5f663552-71c0-4365-9b94-6ff118d12f4f 37 fields · synced Jun 8, 2026