Primary Device ID | 00190746056352 |
NIH Device Record Key | 645a7630-5329-4061-9212-f889d284dcda |
Commercial Distribution Discontinuation | 2018-12-17 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Auxillary |
Version Model Number | 851-639 |
Catalog Number | 851-639 |
Company DUNS | 044668515 |
Company Name | AMERICAN ORTHODONTICS CORPORATION |
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 | true |
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 | true |
OTC Over-The-Counter | false |
Phone | 800-558-7687 |
info@americnaortho.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190746056352 [Primary] |
ECO | Spring, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-12-18 |
Device Publish Date | 2017-10-25 |
00190746060533 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 1ST BICUSPID 022 T-12 A+2 R=0 |
00190746060557 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 1ST BICUSPID 022 T-12 A+2 R=0 W/HK DIST |
00190746060564 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 1ST BICUSPID 022 T-17 A=0 R=0 |
00190746060571 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 1ST BICUSPID 022 T-17 A=0 R=0 W/HK DIST |
00190746060595 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BICUSPID 022 T-17 A+2 R=0 |
00190746060601 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BICUSPID 022 T-17 A+2 R=0 W/HK DIST |
00190746060618 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BICUSPID 022 T-22 A=0 R=0 |
00190746060632 - Empower Clear | 2024-04-19 COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BICUSPID 022 T-22 A=0 R=0 W/HK DIST |