Cerafix® Dura Substitute
GUDID 00854258006013
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 Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic| Primary Device ID | 00854258006013 |
| NIH Device Record Key | 2ee35b72-66cd-4145-ba90-d2cd617a6b7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cerafix® Dura Substitute |
| Version Model Number | C1-1X3 |
| 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 | 1 Inch |
| Width | 1 Inch |
| Width | 1 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 Inch |
| Length | 7.5 Centimeter |
| Width | 2.5 Centimeter |
| Length | 3 Inch |
| Width | 1 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 | 00854258006013 [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 |
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