Enduragen 89224
GUDID 10884521190702
Collagen Implant
SOFRADIM PRODUCTION
Multi-purpose surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial| Primary Device ID | 10884521190702 |
| NIH Device Record Key | cf5eda27-f173-4387-86fa-91f63a943517 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enduragen |
| Version Model Number | 89224 |
| Catalog Number | 89224 |
| Company DUNS | 576342646 |
| Company Name | SOFRADIM PRODUCTION |
| 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 | false |
| 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
| Length | 2 Centimeter |
| Depth | 1 Millimeter |
| Width | 5 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521190702 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013625
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 | 2019-04-22 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Enduragen]
| 10884521190702 | Collagen Implant |
| 10884521190696 | Collagen Implant |
| 10884521190689 | Collagen Implant |
| 10884521196070 | Collagen Implant |
| 10884521196063 | Collagen Implant |
| 10884521190719 | Collagen Implant |
Trademark Results [Enduragen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDURAGEN 76547704 3060682 Live/Registered |
COVIDIEN AG 2003-09-26 |
 ENDURAGEN 76062349 2889476 Dead/Cancelled |
Triarco Industries, Inc. 2000-06-02 |
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