FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DuraGen Plus™ Spinal Matrix
DI: 10381780070726
·
Model: 51100213
·
Integra Lifesciences Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- DuraGen Plus™ Spinal Matrix
- Primary DI
- 10381780070726
- Version / Model
- 51100213
- Catalog Number
- 51100213
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-09-22
- Public Version
- 5
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 7fc71b32-47dd-4305-a16c-09e5b49fca8a
- Distribution End Date
- 2015-09-24
Device Description
DuraGen Plus Dural Regeneration Matrix- Spinal Matrix is an absorbable implant for repair of dural defects. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is two 1 inch x 3 inch (2.5cm x 7.5xm) dural regeneration matrices supplied sterile, non-pyrogenic, for single use in double peel packages.
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 45829 | Dura mater graft, bovine | A xenograft made from bovine dura mater or bovine pericardium used for the repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura and resorbs within 9 to 12 months after surgery. It may be supplied in strips of various sizes and shapes (e.g., square or rectangular) and in a sterile, dry state with treated surfaces. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780070726 | GS1 | ||||
| Unit of Use | 00381780070729 | GS1 | ||||
| Secondary | M269511002131 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092388 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 inch x 3 inch (2.5cm x 7.5cm) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.