Zilver ZILBS-10-8
GUDID 10827002257310
Zilver Expandable Metal Biliary Stent System
COOK INCORPORATED
Bare-metal biliary stent| Primary Device ID | 10827002257310 |
| NIH Device Record Key | 2a0e7c86-4f46-4a8f-af2e-097d38328b03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zilver |
| Version Model Number | G25731 |
| Catalog Number | ZILBS-10-8 |
| Company DUNS | 079720472 |
| Company Name | COOK INCORPORATED |
| 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 | true |
| 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 dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10827002257310 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K020788
FDA Product Code
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
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 | 2022-04-08 |
| Device Publish Date | 2015-11-03 |
On-Brand Devices [Zilver]
| 10827002257259 | Zilver Expandable Metal Biliary Stent System |
| 10827002257242 | Zilver Expandable Metal Biliary Stent System |
| 10827002257235 | Zilver Expandable Metal Biliary Stent System |
| 10827002257266 | Zilver Expandable Metal Biliary Stent System |
| 10827002257310 | Zilver Expandable Metal Biliary Stent System |
| 10827002257303 | Zilver Expandable Metal Biliary Stent System |
| 10827002257297 | Zilver Expandable Metal Biliary Stent System |
| 10827002257280 | Zilver Expandable Metal Biliary Stent System |
| 10827002257273 | Zilver Expandable Metal Biliary Stent System |
Trademark Results [Zilver]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZILVER 79245942 not registered Live/Pending |
Revloz Limited 2018-06-18 |
 ZILVER 78463605 not registered Dead/Abandoned |
Quest Imports International LLC 2004-08-06 |
 ZILVER 75743508 2399643 Live/Registered |
COOK MEDICAL TECHNOLOGIES LLC 1999-07-02 |
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