Cure Dextra
GUDID 10815947021257
Closed System Single Urinary Catheterization System, Straight Tip
CURE MEDICAL LLC
Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter| Primary Device ID | 10815947021257 |
| NIH Device Record Key | a6c8acb7-2121-453b-90b3-5187dc87346d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cure Dextra |
| Version Model Number | DEX14 |
| Company DUNS | 070643426 |
| Company Name | CURE MEDICAL LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815947021250 [Primary] |
| GS1 | 10815947021257 [Package] Contains: 00815947021250 Package: Case [90 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080881
FDA Product Code
| KOD | Catheter, Urological |
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 | 2020-09-07 |
| Device Publish Date | 2020-08-28 |
On-Brand Devices [Cure Dextra]
| 10815947021271 | Closed System Single Urinary Catheterization System, Straight Tip |
| 10815947021264 | Closed System Single Urinary Catheterization System, Straight Tip |
| 10815947021257 | Closed System Single Urinary Catheterization System, Straight Tip |
| 00815947021243 | Closed System Single Urinary Catheterization System, Straight Tip |
| 00815947021236 | Closed System Single Urinary Catheterization System, Straight Tip |
Trademark Results [Cure Dextra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CURE DEXTRA 88489040 not registered Live/Pending |
Cure Medical LLC 2019-06-25 |
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