Echotip Ultra ECHO-22-F
GUDID 00827002037939
Echotip Ultra Fiducial Needle
COOK INCORPORATED
Imaging lesion localization marker, implantable| Primary Device ID | 00827002037939 |
| NIH Device Record Key | 68e58b45-c012-4a3c-9d08-6bad04223578 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Echotip Ultra |
| Version Model Number | G03793 |
| Catalog Number | ECHO-22-F |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002037939 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141356
FDA Product Code
| NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE |
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 | 2018-07-06 |
| Device Publish Date | 2015-11-03 |
Devices Manufactured by COOK INCORPORATED
| 00827002607842 - COOK | 2025-07-30 |
| 00827002607859 - COOK | 2025-07-30 |
| 10827002597508 - COOK | 2025-07-21 Tesla BiCord Active Cord |
| 10827002496535 - Cotton-Leung Sof-Flex | 2025-03-03 Cotton-Leung Sof-Flex Biliary Stent |
| 00827002352674 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352681 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352698 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352704 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
Trademark Results [Echotip Ultra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ECHOTIP ULTRA 90492336 not registered Live/Pending |
Cook Medical Technologies LLC 2021-01-27 |
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