Primary Device ID | 20705031230887 |
NIH Device Record Key | ee717b15-5600-4691-a135-60b6d4af58e5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACCLARENT AERA |
Version Model Number | EU061655 |
Catalog Number | EU061655 |
Company DUNS | 361092450 |
Company Name | ACCLARENT, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(877)775-2789 |
xx@xx.xx |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705031230880 [Primary] |
GS1 | 20705031230887 [Package] Contains: 10705031230880 Package: BOX [5 Units] In Commercial Distribution |
PNZ | Eustachian tube balloon dilation device |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-01-22 |
Device Publish Date | 2016-11-17 |
20705031230870 | ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1 PK |
20705031230887 | ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ACCLARENT AERA 86261549 5142131 Live/Registered |
ACCLARENT, INC. 2014-04-24 |