RELIEVA SPINPLUS RSP0516M
GUDID 20705031232874
RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 M-110C GUIDE KIT
ACCLARENT, INC.
Epistaxsis balloon| Primary Device ID | 20705031232874 |
| NIH Device Record Key | f6b26520-3062-4d78-bdc6-ed550b76d637 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RELIEVA SPINPLUS |
| Version Model Number | RSP0516M |
| Catalog Number | RSP0516M |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705031232877 [Primary] |
| GS1 | 20705031232874 [Package] Contains: 10705031232877 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143541
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 SPINPLUS]
| 20705031233062 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 NO GUIDE KIT, 1 PK |
| 20705031233048 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 NO GUIDE KIT, 1 PK |
| 20705031232928 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 M-110C GUIDE KIT, 1 PK |
| 20705031232904 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 F-70 GUIDE KIT, 1 PK |
| 20705031232867 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 M-110C GUIDE KIT, 1 PK |
| 20705031232843 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 F-70 GUIDE KIT, 1 PK |
| 20705031232829 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 3 GUIDE KIT, 1 PK |
| 20705031232812 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 3 GUIDE KIT, 1 PK |
| 20705031233055 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 NO GUIDE KIT |
| 20705031233031 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 NO GUIDE KIT |
| 20705031232935 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 M-110C GUIDE KIT |
| 20705031232911 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 F-70 GUIDE KIT |
| 20705031232874 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 M-110C GUIDE KIT |
| 20705031232850 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 F-70 GUIDE KIT |
| 20705031232836 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 5x16 3 GUIDE KIT |
| 20705031232386 | RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM, 6x16 3 GUIDE KIT |
Trademark Results [RELIEVA SPINPLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIEVA SPINPLUS 86487044 4886857 Live/Registered |
ACCLARENT, INC. 2014-12-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.