Identity
- Trade Name
- SURE-LOCK FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- SURE LOCK,A34,10 PK,BLUE LEVER,MIDMARK FDA UDI
- Model / Reference
- SLC-4105-610 FDA UDI
- Description
- SURE LOCK,A34,10 PK,BLUE LEVER,MIDMARK FDA UDI
Identifiers
- Catalog Number
- 13412 FDA UDI
- Primary DI / UDI-DI
- 00840828146326 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
- 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
Category: Electrocardiographic electrode, reusable
Sure-Lock by Curbell Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, reusable.
- GE Healthcare — SHENZHEN LAUNCH ELECTRICAL CO., LTD · Class II
- ZENIX — Zoll Medical Corporation · Class III
- APK — Apk Technology · Class II
- APK — Apk Technology · Class II
- APK — Apk Technology · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- APK — Apk Technology · Class II
- Neutral Cable — Chungwoo Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI a89f40b6-07f3-44f6-80b1-2731120d7455 36 fields · synced May 30, 2026