RELIEVA TRACT RT1040A
GUDID 20705031462585
RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM
ACCLARENT, INC.
Nasal/paranasal balloon catheter| Primary Device ID | 20705031462585 |
| NIH Device Record Key | 551b811d-c492-4a0c-b106-d66a41169d8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RELIEVA TRACT |
| Version Model Number | RT1040A |
| Catalog Number | RT1040A |
| 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(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 | |
| 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(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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705031462588 [Primary] |
| GS1 | 20705031462585 [Package] Contains: 10705031462588 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183090
FDA Product Code
| QGK | Balloon, nasal airway |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2019-05-31 |
On-Brand Devices [RELIEVA TRACT]
| 20705031462653 | RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK |
| 20705031462639 | RELIEVA TRACT BALLOON DILATION SYSTEM, 14X40MM - 1PK |
| 20705031462615 | RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM - 1PK |
| 20705031462592 | RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM - 1PK |
| 20705031462646 | RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM |
| 20705031462622 | RELIEVA TRACT BALLOON DILATION SYSTEM, 14X40MM |
| 20705031462608 | RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM |
| 20705031462585 | RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM |
Trademark Results [RELIEVA TRACT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIEVA TRACT 88298874 not registered Live/Pending |
Acclarent, Inc. 2019-02-12 |
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