SureLead
GUDID B631DLSGPHP5P11F1
Authentic Medical
Electrocardiographic lead set, single-use| Primary Device ID | B631DLSGPHP5P11F1 |
| NIH Device Record Key | 550d057b-0d97-4cc0-b57d-5391ec1cce98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureLead |
| Version Model Number | DLSGPHP5P11F |
| Company DUNS | 078861998 |
| Company Name | Authentic Medical |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B631DLSGPHP5P11F1 [Primary] |
FDA Product Code
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-15 |
| Device Publish Date | 2022-09-07 |
On-Brand Devices [SureLead]
Trademark Results [SureLead]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURELEAD 98844045 not registered Live/Pending |
Authentic Options LLC 2024-11-08 |
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