American Medicals
GUDID B356KE501040
American Medicals
Endodontic obturation material distribution endpiece, reusable| Primary Device ID | B356KE501040 |
| NIH Device Record Key | 847003c1-3433-4f7e-b4db-f0bb14371394 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | American Medicals |
| Version Model Number | 1 |
| Company DUNS | 109909627 |
| Company Name | American Medicals |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | B356KE501040 [Primary] |
FDA Product Code
| MDM | Instrument, Manual, Surgical, General Use |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
[B356KE501040]
Microwave Radiation
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-14 |
| Device Publish Date | 2024-06-06 |
On-Brand Devices [American Medicals]
Trademark Results [American Medicals]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMERICAN MEDICALS 98716697 not registered Live/Pending |
Bihani Corporation 2024-08-26 |
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