FDA UDI
In Commercial Distribution
🇺🇸 United States
Novapak
DI: 20643169662227
·
Model: CS3600-2
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Novapak
- Primary DI
- 20643169662227
- Version / Model
- CS3600-2
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-02-08
- Public Version
- 1
- Public Version Date
- 2021-02-16
- Public Version Status
- New
- Public Device Record Key
- 12a059a6-023c-4898-a3ec-4fdc9d06861c
Device Description
NASAL PACKING CS3600-2 NOVAPAK 2PK STD
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
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 44434 | ENT space-occupying dressing, animal-derived | A sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery or trauma. It is typically available as a gel or gelatin sponge; it contains animal-derived components (e.g., collagen), and may additionally contain microbe-derived (biosynthetic) components [e.g., hyaluronic acid (HA)]. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00643169662223 | GS1 | ||||
| Primary | 20643169662227 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202623 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Novapak at room temperature