FDA UDI
In Commercial Distribution
🇺🇸 United States
Cerafix® Dura Substitute
DI: 00854258006006
·
Model: C1-1X1
·
Acera Surgical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cerafix® Dura Substitute
- Primary DI
- 00854258006006
- Version / Model
- C1-1X1
- Company Name
- Acera Surgical Inc
- Labeler DUNS
- 040631370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-07
- Public Version
- 3
- Public Version Date
- 2021-09-02
- Public Version Status
- Update
- Public Device Record Key
- 0520367d-d656-44a5-bd52-c3b6c0c32c12
Device Description
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable,nonfriable, porous polymer matrix.
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
- No
- 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 |
|---|---|---|---|---|
| GXQ | Dura Substitute | Neurology | 882.5910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58044 | Dura mater graft, synthetic | A sterile device made from synthetic polymers [e.g., expanded polytetrafluoroethylene (ePTFE), ePTFE/elastic fluoropolymer) intended to be used for the temporary or permanent 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; it is typically supplied in the form of a patch and may be sutured into place. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854258006006 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2.5 | Centimeter | |
| Length | 2.5 | Centimeter | |
| Width | 1 | Inch | |
| Length | 1 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.