SialoCath SDC-2.2-20
GUDID 00827002351660
SialoCath Salivary Duct Catheter
COOK INCORPORATED
Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter Salivary irrigation catheter| Primary Device ID | 00827002351660 |
| NIH Device Record Key | 64f1a5ff-5f45-47ef-b7a7-319a3a9fa388 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SialoCath |
| Version Model Number | G35166 |
| Catalog Number | SDC-2.2-20 |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002351660 [Primary] |
FDA Product Code
| OAJ | catheter, drainage, intraoral/extraoral |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
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 [SialoCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIALOCATH 86761410 4953278 Live/Registered |
Cook Medical Technologies LLC 2015-09-18 |
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