Sof-Flex 039700-S23
GUDID 00827002158986
Sof-Flex Multi-Length Ureteral Stent Set
COOK INCORPORATED
Polymeric ureteral stent| Primary Device ID | 00827002158986 |
| NIH Device Record Key | cc8eb861-bbce-4df0-8bcd-323b8593b38a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sof-Flex |
| Version Model Number | G15898 |
| Catalog Number | 039700-S23 |
| Company DUNS | 042823948 |
| 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
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002158986 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180053
FDA Product Code
| FAD | Stent, ureteral |
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 | 2020-05-08 |
| Device Publish Date | 2020-04-30 |
On-Brand Devices [Sof-Flex]
| 00827002153974 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002151505 | Sof-Flex Multi-Length Ureteral Stent Set |
| 00827002151383 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002150935 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002150775 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002150768 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002150638 | Sof-Flex, Ileal Conduit Pigtail Catheter Set |
| 00827002150386 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002150263 | Sof-Flex Loop Suprapubic Catheter Set |
| 00827002150256 | Sof-Flex Loop Suprapubic Catheter Set |
| 00827002150034 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002150003 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002149915 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002149809 | Sof-Flex, Pigtail Ureteral Catheter Set, Right |
| 00827002149564 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002149519 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002149434 | Sof-Flex Large Diameter Double Pigtail Ureteral Stent Set |
| 00827002149342 | Sof-Flex Loop Suprapubic Catheter Set |
| 00827002149236 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002149069 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148987 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148673 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148666 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148659 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148543 | Sof-Flex Large Diameter Double Pigtail Ureteral Stent Set |
| 00827002148499 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148437 | Sof-Flex Large Diameter Double Pigtail Ureteral Stent Set |
| 00827002148413 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148406 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148321 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002148307 | Sof-Flex Large Diameter Double Pigtail Ureteral Stent Set |
| 00827002148253 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002147973 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002147904 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002147898 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002147881 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002147836 | Sof-Flex Multi-Length Ureteral Stent Set |
| 00827002147737 | Sof-Flex Multi-Length Ureteral Stent Set |
| 00827002147614 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002147522 | Sof-Flex, Rankin Ureteral Ileal Conduit Stent Set With PTFE Amplatz Extra Stiff Wire Guide |
| 00827002270596 | Sof-Flex Double Pigtail Ureteral Stent Set |
| 00827002189973 | Sof-Flex AQ, Pigtail Ureteral Catheter With AQ, Hydrophilic Coating |
| 00827002189966 | Sof-Flex AQ, Pigtail Ureteral Catheter With AQ, Hydrophilic Coating |
| 00827002188846 | Sof-Flex AQ, Pigtail Ureteral Catheter With AQ, Hydrophilic Coating |
| 00827002188471 | Sof-Flex, Rankin Ureteral Ileal Conduit Stent Set With PTFE Amplatz Extra Stiff Wire Guide |
| 00827002178526 | Sof-Flex Multi-Length Ureteral Stent Set |
| 00827002177932 | Sof-Flex Pediatric Double Pigtail Ureteral Stent Set |
| 00827002176768 | Sof-Flex Pediatric Dbl Pigtail Ureteral Stent Set |
| 00827002171619 | Open-End Ureteral Catheter Sof-Flex |
| 00827002169036 | Sof-Flex, Rankin Ureteral Ileal Conduit Stent Set With PTFE Amplatz Extra Stiff Wire Guide |
Trademark Results [Sof-Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOF-FLEX 74712174 1985689 Live/Registered |
BERRY FILM PRODUCTS COMPANY, INC. 1995-08-07 |
 SOF-FLEX 74193474 1723539 Dead/Cancelled |
DEXIDE, INC. 1991-08-12 |
 SOF-FLEX 73683935 1488279 Live/Registered |
VANCE PRODUCTS INCORPORATED 1987-09-14 |
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