Echotip Ultra ECHO-22-F
GUDID 00827002037939
Echotip Ultra Fiducial Needle
COOK INCORPORATED
Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image 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
| 00827002214521 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002215009 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002217652 - COOK | 2024-04-03 CLASSIC ERCP CATHETER |
| 00827002218680 - COOK | 2024-04-03 HUIBREGTSE-KATON ERCP CATHETER |
| 00827002219656 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002220300 - COOK | 2024-04-03 CLASSIC ERCP CATHETER |
| 00827002220935 - COOK | 2024-04-03 GLO-TIP ERCP CATHETER |
| 00827002222267 - COOK | 2024-04-03 GLO-TIP II DOUBLE LUMEN ERCP CATHETER |
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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