Durepair™ 62105
GUDID 10381780540892
Durepair™ 7.5cm x 7.5cm (3" x 3")
TEI BIOSCIENCES INC.
Dura mater graft, bovine| Primary Device ID | 10381780540892 |
| NIH Device Record Key | a936a0b5-e4f0-48df-8505-d9673880d91a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Durepair™ |
| Version Model Number | 62105 |
| Catalog Number | 62105 |
| 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 | true |
| 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 |
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 |
Device Dimensions
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
| Width | 3 Inch |
| Length | 7.5 Centimeter |
| Length | 3 Inch |
| Width | 7.5 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169063860 [Previous] |
| GS1 | 10381780540892 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161370
FDA Product Code
| GXQ | DURA SUBSTITUTE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-10 |
| Device Publish Date | 2025-01-31 |
On-Brand Devices [Durepair™]
| 10381780540892 | Durepair™ 7.5cm x 7.5cm (3" x 3") |
| 10381780540878 | Durepair™ 2.5cm x 2.5cm (1" x 1") |
| 10381780540854 | Durepair™ 5.0cm x 5.0cm (2" x 2") |
| 10381780540786 | Durepair™ 12.5cm x 20.0cm (5" x 8") |
Trademark Results [Durepair]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUREPAIR 78015607 2813992 Live/Registered |
TEI BIOSCIENCE INC. 2000-07-06 |
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