| Primary Device ID | 00841013120435 |
| NIH Device Record Key | 291c2fc3-9ec4-44a5-a330-e3443d7f4fc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | American Eagle Instruments, Inc. |
| Version Model Number | AEFH3-7XPZ |
| Catalog Number | AEFH3-7XPZ |
| Company DUNS | 790776850 |
| Company Name | AMERICAN EAGLE INSTRUMENTS, INC. |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00841013120435 [Primary] |
| EKK | Spreader, Pulp Canal Filling Material, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
[00841013120435]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-26 |
| Device Publish Date | 2025-02-18 |
| 00841013120442 | HIRSCHFELD 5-11 FILE XP (3/8) SS |
| 00841013120435 | HIRSCHFELD 3-7 FILE XP (3/8) SS |