FDA UDI
In Commercial Distribution
🇺🇸 United States
RELIEVA SPIN
DI: 10705031200586
·
Model: RSF70
·
ACCLARENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RELIEVA SPIN
- Primary DI
- 10705031200586
- Version / Model
- RSF70
- Catalog Number
- RSF70
- Company Name
- ACCLARENT, INC.
- Labeler DUNS
- 361092450
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-01
- Public Version
- 6
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 44c25cb5-707e-40d0-ac9d-c14d8eae8936
Device Description
RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, F-70 SINUS GUIDE CATHETER TIP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12699 | Nasal haemostatic balloon | A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705031200583 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 10705031200586 | GS1 |
Customer Contacts
- Phone
- +1(650)687-5888
- [email protected]
- Phone
- +1(877)775-2789
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111875 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place