SurgiPure® XD 254015XD
GUDID 05060260020106
Reconstructive Tissue Matrix
Tissue Regenix Wound Care Inc.
Multi-purpose surgical mesh, collagen, bioabsorbable| Primary Device ID | 05060260020106 |
| NIH Device Record Key | 25303efe-28c6-4ebc-86ce-7a2fb30f19cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiPure® XD |
| Version Model Number | 254015XD |
| Catalog Number | 254015XD |
| Company DUNS | 031826073 |
| Company Name | Tissue Regenix Wound Care 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 | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
| Depth | 1.5 Centimeter |
| Length | 40 Centimeter |
| Width | 25 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060260020106 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152206
FDA Product Code
| FTM | Mesh, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
On-Brand Devices [SurgiPure® XD]
| 05060260020120 | Reconstructive Tissue Matrix |
| 05060260020113 | Reconstructive Tissue Matrix |
| 05060260020106 | Reconstructive Tissue Matrix |
| 05060260020090 | Reconstructive Tissue Matrix |
| 05060260020083 | Reconstructive Tissue Matrix |
| 05060260020076 | Reconstructive Tissue Matrix |
| 05060260020069 | Reconstructive Tissue Matrix |
| 05060260020052 | Reconstructive Tissue Matrix |
| 05060260020045 | Reconstructive Tissue Matrix |
| 05060260020038 | Reconstructive Tissue Matrix |
| 05060260020021 | Reconstructive Tissue Matrix |
| 05060260020014 | Reconstructive Tissue Matrix |
Trademark Results [SurgiPure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIPURE 86402866 5586445 Live/Registered |
Tissue Regenix Group Plc 2014-09-23 |
 SURGIPURE 85571055 not registered Dead/Abandoned |
APPLIED SILICONE CORPORATION 2012-03-15 |
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