Cerafix® Dura Substitute
GUDID 00854258006051
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.
ACERA SURGICAL INC
Dura mater graft, synthetic| Primary Device ID | 00854258006051 |
| NIH Device Record Key | 80d35a0b-73f9-4918-8ed4-7fda54456f0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cerafix® Dura Substitute |
| Version Model Number | C1-5X7 |
| Company DUNS | 040631370 |
| Company Name | ACERA SURGICAL INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Width | 5 Inch |
| Width | 5 Inch |
| Width | 5 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
| Length | 17.5 Centimeter |
| Width | 12.5 Centimeter |
| Length | 7 Inch |
| Width | 5 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854258006051 [Primary] |
FDA Product Code
| GXQ | Dura Substitute |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-07 |
On-Brand Devices [Cerafix® Dura Substitute]
| 00854258006051 | Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used |
| 00854258006044 | Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used |
| 00854258006037 | Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used |
| 00854258006020 | Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used |
| 00854258006013 | Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used |
| 00854258006006 | Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used |
Trademark Results [Cerafix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERAFIX 86345694 4806739 Live/Registered |
Acera Surgical, Inc. 2014-07-23 |
 CERAFIX 76565838 2957853 Dead/Cancelled |
ALLEGHANY PHARMACAL CORPORATION 2003-12-18 |
 CERAFIX 73463856 1311793 Dead/Cancelled |
Ceraver 1984-02-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.