FDA UDI
In Commercial Distribution
🇺🇸 United States
DuraMend Suturable
DI: 00813954022611
·
Model: NDMS33
·
COLLAGEN MATRIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DuraMend Suturable
- Primary DI
- 00813954022611
- Version / Model
- NDMS33
- Catalog Number
- NDMS33
- Company Name
- COLLAGEN MATRIX, INC.
- Labeler DUNS
- 176262442
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-22
- Public Version
- 1
- Public Version Date
- 2023-08-30
- Public Version Status
- New
- Public Device Record Key
- e2231761-68c4-4680-96a3-2b0aee64c745
Device Description
Collagen Dura Membrane
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 |
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 | 00813954022611 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 in x 3 in (7.5 cm x 7.5 cm) |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit