SurgiMend®
GUDID 10381780357377
SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction
TEI BIOSCIENCES INC.
Extra-gynaecological surgical mesh, collagen, non-bioabsorbable| Primary Device ID | 10381780357377 |
| NIH Device Record Key | 0f9c0f70-f64f-4230-8d29-7914c19092f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiMend® |
| Version Model Number | 606-206-005 |
| Company DUNS | 796253292 |
| Company Name | TEI BIOSCIENCES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from excessive heat and direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780357377 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162965
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 | 5 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2017-05-26 |
On-Brand Devices [SurgiMend®]
| 10381780113287 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113270 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113263 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113256 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113249 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113232 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113225 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113218 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113201 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113195 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113188 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113171 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113164 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113157 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113140 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113133 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113126 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113119 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113102 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113096 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113089 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113072 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113065 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113041 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113034 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113010 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780113003 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112990 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112983 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112976 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112952 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112921 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112914 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112891 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112884 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112877 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112860 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112853 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112846 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112839 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112822 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112815 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112808 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112792 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112785 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112778 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112761 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112747 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112723 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
| 10381780112716 | SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl |
Trademark Results [SurgiMend]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIMEND 77243474 3408647 Live/Registered |
TEI Biosciences Inc. 2007-07-31 |
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