RELIEVA SPIN RS0516MFS
GUDID 20705031230573
RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 3 GUIDE KIT
ACCLARENT, INC.
Epistaxsis balloon| Primary Device ID | 20705031230573 |
| NIH Device Record Key | d35d04d7-314c-4306-84c2-f86c8c615925 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RELIEVA SPIN |
| Version Model Number | RS0516MFS |
| Catalog Number | RS0516MFS |
| 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 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| Phone | +1(877)775-2789 |
| xx@xx.xx | |
| 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 | |
| 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 |
| 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 | 10705031230576 [Primary] |
| GS1 | 20705031230573 [Package] Contains: 10705031230576 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111875
FDA Product Code
| LRC | INSTRUMENT, ENT MANUAL SURGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2016-10-01 |
On-Brand Devices [RELIEVA SPIN]
| 20705031230580 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 6x16 3 GUIDE KIT, 1 PK |
| 20705031230566 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 3 GUIDE KIT, 1 PK |
| 20705031227580 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, M-110C SINUS GUIDE CATHETER TIP, 1 PK |
| 20705031206370 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 F-70 GUIDE KIT, 1 PK |
| 20705031206325 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 M-110C GUIDE KIT, 1 PK |
| 20705031206042 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, M-110 SINUS GUIDE CATHETER TIP, 1 PK |
| 20705031206011 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, S-0 SINUS GUIDE CATHETER TIP, 1 PK |
| 20705031200576 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 6x16 M-110 GUIDE KIT, 1 PK |
| 20705031200545 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 6x16 F-70 GUIDE KIT, 1 PK |
| 20705031200538 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, F-70 SINUS GUIDE CATHETER TIP, 1 PK |
| 20705031230597 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 6x16 3 GUIDE KIT |
| 20705031230573 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 3 GUIDE KIT |
| 20705031227573 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, M-110C SINUS GUIDE CATHETER TIP |
| 20705031206318 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 M-110C GUIDE KIT |
| 20705031206301 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 F-70 GUIDE KIT |
| 20705031206035 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, M-110 SINUS GUIDE CATHETER TIP |
| 20705031206028 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, S-0 SINUS GUIDE CATHETER TIP |
| 20705031200583 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, F-70 SINUS GUIDE CATHETER TIP |
| 20705031200569 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 6x16 M-110 GUIDE KIT |
| 20705031200552 | RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 6x16 F-70 GUIDE KIT |
Trademark Results [RELIEVA SPIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIEVA SPIN 85436310 4335661 Dead/Cancelled |
ACCLARENT, INC. 2011-09-30 |
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