FDA UDI
In Commercial Distribution
🇺🇸 United States
DURASIS
DI: 00810179630003
·
Model: NXDUR0203
·
COOK BIOTECH INCORPORATED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DURASIS
- Primary DI
- 00810179630003
- Version / Model
- NXDUR0203
- Catalog Number
- NXDUR0203
- Company Name
- COOK BIOTECH INCORPORATED
- Labeler DUNS
- 945385862
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-20
- Public Version
- 1
- Public Version Date
- 2025-02-28
- Public Version Status
- New
- Public Device Record Key
- fb6149b9-7a12-4e2a-adea-8610d74f0573
Device Description
Durasis Dural Graft
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GXQ | Dura Substitute | Neurology | 882.5910 | 2 |
| FTM | Mesh, Surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48155 | Dura mater biomatrix implant | A bioabsorbable device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810179630003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160869 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.