FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE PRECLUDE Dura Substitute
DI: 00733132601936
·
Model: 1PDS152
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GORE PRECLUDE Dura Substitute
- Primary DI
- 00733132601936
- Version / Model
- 1PDS152
- Catalog Number
- 1PDS152
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-07
- Public Version
- 5
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- 9a6d90f2-4668-4743-9288-437159858660
Device Description
GORE PRECLUDE DURA SUBSTITUTE 15.0cmX20.0cmX0.1mm
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00733132601936 | GS1 |
Customer Contacts
- Phone
- 8005288763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953969 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 15 | Centimeter | |
| Length | 20 | Centimeter |