Herculink Elite 1011495-12
GUDID 08717648078064
RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 12 mm x 80 cm
ABBOTT VASCULAR INC.
Bare-metal biliary stent| Primary Device ID | 08717648078064 |
| NIH Device Record Key | 759b0675-731d-4d0a-aed6-b1574a9e9290 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Herculink Elite |
| Version Model Number | 1011495-12 |
| Catalog Number | 1011495-12 |
| Company DUNS | 964569052 |
| Company Name | ABBOTT VASCULAR INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717648078064 [Primary] |
FDA Product Code
| NIN | STENT, RENAL |
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 | 2021-02-05 |
| Device Publish Date | 2014-11-21 |
On-Brand Devices [Herculink Elite]
| 08717648078385 | RX Herculink Elite Renal and Biliary Stent System 7.0 mm x 18 mm x 135 cm |
| 08717648078378 | RX Herculink Elite Renal and Biliary Stent System 7.0 mm x 15 mm x 135 cm |
| 08717648078354 | RX Herculink Elite Renal and Biliary Stent System 7.0 mm x 18 mm x 80 cm |
| 08717648078347 | RX Herculink Elite Renal and Biliary Stent System 7.0 mm x 15 mm x 80 cm |
| 08717648078293 | RX Herculink Elite Renal and Biliary Stent System 6.5 mm x 18 mm x 135 cm |
| 08717648078286 | RX Herculink Elite Renal and Biliary Stent System 6.5 mm x 15 mm x 135 cm |
| 08717648078279 | RX Herculink Elite Renal and Biliary Stent System 6.5 mm x 12 mm x 135 cm |
| 08717648078262 | RX Herculink Elite Renal and Biliary Stent System 6.5 mm x 18 mm x 80 cm |
| 08717648078255 | RX Herculink Elite Renal and Biliary Stent System 6.5 mm x 15 mm x 80 cm |
| 08717648078248 | RX Herculink Elite Renal and Biliary Stent System 6.5 mm x 12 mm x 80 cm |
| 08717648078200 | RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 18 mm x 135 cm |
| 08717648078194 | RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 15 mm x 135 cm |
| 08717648078187 | RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 12 mm x 135 cm |
| 08717648078170 | RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 18 mm x 80 cm |
| 08717648078163 | RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 15 mm x 80 cm |
| 08717648078156 | RX Herculink Elite Renal and Biliary Stent System 6.0 mm x 12 mm x 80 cm |
| 08717648078118 | RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 18 mm x 135 cm |
| 08717648078101 | RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 15 mm x 135 cm |
| 08717648078095 | RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 12 mm x 135 cm |
| 08717648078088 | RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 18 mm x 80 cm |
| 08717648078071 | RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 15 mm x 80 cm |
| 08717648078064 | RX Herculink Elite Renal and Biliary Stent System 5.5 mm x 12 mm x 80 cm |
| 08717648078026 | RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 18 mm x 135 cm |
| 08717648078019 | RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 15 mm x 135 cm |
| 08717648078002 | RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 12 mm x 135 cm |
| 08717648077999 | RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 18 mm x 80 cm |
| 08717648077982 | RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 15 mm x 80 cm |
| 08717648077975 | RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 12 mm x 80 cm |
| 08717648077937 | RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 18 mm x 135 cm |
| 08717648077920 | RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 15 mm x 135 cm |
| 08717648077913 | RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 12 mm x 135 cm |
| 08717648077906 | RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 18 mm x 80 cm |
| 08717648077890 | RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 15 mm x 80 cm |
| 08717648077883 | RX Herculink Elite Renal and Biliary Stent System 4.5 mm x 12 mm x 80 cm |
| 08717648077845 | RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 18 mm x 135 cm |
| 08717648077838 | RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 15 mm x 135 cm |
| 08717648077821 | RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 12 mm x 135 cm |
| 08717648077814 | RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 18 mm x 80 cm |
| 08717648077807 | RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 15 mm x 80 cm |
| 08717648077791 | RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 12 mm x 80 cm |
Trademark Results [Herculink Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HERCULINK ELITE 78572429 3681482 Live/Registered |
ABBOTT CARDIOVASCULAR SYSTEMS, INC. 2005-02-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.