FDA UDI
In Commercial Distribution
🇺🇸 United States
Nasopore
DI: 07613154340798
·
Model: 5400010004
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nasopore
- Primary DI
- 07613154340798
- Version / Model
- 5400010004
- Catalog Number
- 5400-010-004
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 6
- Public Version Date
- 2022-03-23
- Public Version Status
- Update
- Public Device Record Key
- b22a938e-a9bf-41aa-9217-98172de1992e
Device Description
Standard 4cm
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LYA | SPLINT, INTRANASAL SEPTAL | Ear, Nose, Throat | 874.4780 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 37613154340799 | GS1 | pack | 8 | In Commercial Distribution | |
| Primary | 07613154340798 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 4 Degrees Celsius