| Primary Device ID | 00841013117541 |
| NIH Device Record Key | 8f57ee41-a054-4ff3-afa6-ac2573c8b196 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swede Dental |
| Version Model Number | SIEXC611-21Z |
| Catalog Number | SIEXC611-21Z |
| Company DUNS | 790776850 |
| Company Name | AMERICAN EAGLE INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com | |
| Phone | +1 (800) 551 5172 |
| customerservice@am-eagle.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841013117541 [Primary] |
| EKC | EXCAVATOR, DENTAL, OPERATIVE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
[00841013117541]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-23 |
| 00841013117923 | SCALER M23 THIN-THIN (3/8) BLACK |
| 00841013117909 | SCALER 204SD (3/8) YELLOW |
| 00841013117886 | PROBE 12 BLACK (3/8) |
| 00841013117862 | SWEDE DENTAL MHR SIMPLE STEM (3/8) |
| 00841013117664 | GRACEY ACCESS 13-14 THIN-THIN (3/8) BLUE/BLUE |
| 00841013117657 | GRACEY ACCESS 1-2 (3/8) PURPLE |
| 00841013117640 | GRACEY ACCESS 11-12 THIN-THIN (3/8)OR/OR |
| 00841013117626 | GRACEY 13-14 THIN-THIN 3/8 BLUE |
| 00841013117619 | GRACEY 11-12 THIN-THIN (3/8) ORANGE |
| 00841013117602 | EXPLORER DE 5 (3/8) |
| 00841013117596 | EXCAVATOR 74-75 (3/8) SS |
| 00841013117589 | EXCAVATOR 70-71 (3/8) SS |
| 00841013117572 | EXCAVATOR 651-61 (3/8) SS |
| 00841013117565 | EXCAVATOR 64-65 (3/8) SS |
| 00841013117541 | EXCAVATOR 611-21 (3/8) SS |
| 00841013117534 | EXPL/PROBE 23/12 (Black)(3/8) |
| 00841013117527 | EXPL/PROBE 23/2-12 BLACK (3/8) |