Soehendra PT-5.5-BII-SOEHENDRA
GUDID 00827002217324
Soehendra Billroth II Sphincterotome
COOK INCORPORATED
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 00827002217324 |
| NIH Device Record Key | 499863ef-3525-424a-96d6-bfbb5d4d2eec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soehendra |
| Version Model Number | G21732 |
| Catalog Number | PT-5.5-BII-SOEHENDRA |
| Company DUNS | 079720472 |
| Company Name | COOK INCORPORATED |
| 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 | 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002217324 [Primary] |
FDA Product Code
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) |
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 | 2019-02-21 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Soehendra]
| 00827002508002 | Soehendra Biliary Dilation Catheter |
| 00827002222052 | Soehendra Stent Retriever |
| 00827002220621 | Soehendra Biliary Dilation Catheter |
| 00827002220461 | Soehendra Biliary Dilation Catheter |
| 00827002219373 | Soehendra Stent Retriever |
| 00827002219342 | Soehendra Stent Retriever |
| 00827002218604 | Soehendra Lithotriptor Handle |
| 00827002217324 | Soehendra Billroth II Sphincterotome |
| 00827002217294 | Soehendra Biliary Dilation Catheter |
| 00827002216617 | Soehendra Stent Retriever |
| 00827002216044 | Soehendra Lithotripsy Cable |
| 00827002215764 | Soehendra Biliary Dilation Catheter |
| 00827002215733 | Soehendra Biliary Dilation Catheter |
| 00827002215719 | Soehendra Biliary Dilation Catheter |
| 00827002215689 | Soehendra Biliary Dilation Catheter |
| 00827002215351 | Soehendra Stent Retriever |
Trademark Results [Soehendra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOEHENDRA 74232968 1800616 Live/Registered |
COOK MEDICAL TECHNOLOGIES LLC 1991-12-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.