ACCLARENT PIVOT PVT0616LZ
GUDID 20705031465586
ACCLARENT PIVOT Illumination Balloon Dilation System - 1PK
ACCLARENT, INC.
Eustachian catheter, single-use| Primary Device ID | 20705031465586 |
| NIH Device Record Key | d9df4f0b-ac54-4110-9757-8017ceea5bda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCLARENT PIVOT |
| Version Model Number | PVT0616LZ |
| Catalog Number | PVT0616LZ |
| 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 |
Customer Support Contacts
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(650)687-5888 |
| xxx@xxx.xxx | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| 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. |
| 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. |
| 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. |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20705031465586 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201115
FDA Product Code
| LRC | INSTRUMENT, ENT MANUAL SURGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-09 |
| Device Publish Date | 2020-10-01 |
On-Brand Devices [ACCLARENT PIVOT]
| 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 |
Trademark Results [ACCLARENT PIVOT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCLARENT PIVOT 88873621 not registered Live/Pending |
Acclarent, Inc. 2020-04-15 |
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