FDA UDI
In Commercial Distribution
🇺🇸 United States
PuraSinus 3mL
DI: 00860001820836
·
Model: 651-008
·
3-D MATRIX INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PuraSinus 3mL
- Primary DI
- 00860001820836
- Version / Model
- 651-008
- Company Name
- 3-D MATRIX INC.
- Labeler DUNS
- 058207695
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-13
- Public Version
- 1
- Public Version Date
- 2022-07-21
- Public Version Status
- New
- Public Device Record Key
- 3588983c-0495-44c5-a02e-e05945218778
Device Description
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
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 |
|---|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41493 | Intranasal splint, biodegradable | A bioabsorbable device intended to be placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made of non-animal source material which chemically degrades after about 3 – 4 weeks and is absorbed via natural body processes, or it may be removed at the discretion of the physician. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001820836 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183015 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius