Primary Device ID | 00841013117589 |
NIH Device Record Key | cb1119ed-bd2f-493a-af61-4cd24d63cff6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Swede Dental |
Version Model Number | SIEXC70-71Z |
Catalog Number | SIEXC70-71Z |
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 | 00841013117589 [Primary] |
EKC | EXCAVATOR, DENTAL, OPERATIVE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
Moist Heat or Steam Sterilization
[00841013117589]
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) |