SureLead DLSPHP6L4F
SureLead DLSPHP6L4F is a Class II device made by Authentic Medical, listed in FDA GUDID since 6 Mar 2018 (UDI-DI B631DLSPHP6L4F1), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB631DLSPHP6L4F1 | Date6 Mar 2018 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SureLead
- Generic name
- Electrocardiographic lead set, single-use
- Model / reference
- DLSPHP6L4F
- Primary DI / UDI-DI
- B631DLSPHP6L4F1
- FDA product code
- DSA
- GMDN term
- Electrocardiographic lead set, single-use
- Device class
- Class II
- Regulation number
- 870.2900
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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