Primary Device ID | 20705031465616 |
NIH Device Record Key | 12f6ae63-d9bf-4b35-aecf-3e52fa5aacef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACCLARENT PIVOT |
Version Model Number | PVT0616Z |
Catalog Number | PVT0616Z |
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 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx | |
Phone | +1(877)775-2789 |
xxx@xxx.xxx |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 20705031465616 [Primary] |
PNZ | Eustachian tube balloon dilation device |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-09 |
Device Publish Date | 2020-10-01 |
20705031465616 | ACCLARENT PIVOT Balloon Dilation System - 1PK |
20705031465609 | ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK |
20705031465586 | ACCLARENT PIVOT Illumination Balloon Dilation System - 1PK |
20705031465593 | ACCLARENT PIVOT Navigation Balloon Dilation System |
20705031465579 | ACCLARENT PIVOT Illumination Balloon Dilation System |
20705031465562 | ACCLARENT PIVOT Balloon Dilation System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ACCLARENT PIVOT 88873621 not registered Live/Pending |
Acclarent, Inc. 2020-04-15 |