Cure Twist®
GUDID 00815947020369
Twist Sterile Female Intermittent Catheter, 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| Primary Device ID | 00815947020369 |
| NIH Device Record Key | dc96d847-64ec-44ee-97d7-d2f0ab69e965 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cure Twist® |
| Version Model Number | T8 |
| 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 |
Customer Support Contacts
| Phone | +18004228811 |
| cic@convatec.com |
Device Dimensions
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Length | 15 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815947020369 [Primary] |
| GS1 | 10815947020366 [Package] Package: Box [30 Units] In Commercial Distribution |
| GS1 | 20815947020363 [Package] Contains: 10815947020366 Package: Case [10 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Cure Twist®]
| 20815947020974 | Twist Sterile Female Catheter with Insertion Kit, Straight Tip |
| 20815947020967 | Twist Sterile Female Catheter with Insertion Kit, Straight Tip |
| 20815947020950 | Twist Sterile Female Catheter with Insertion Kit, Straight Tip |
| 20815947020943 | Twist Sterile Female Catheter with Insertion Kit, Straight Tip |
| 20815947020516 | Twist Sterile Female Catheter with Insertion Kit, Straight Tip |
| 20815947020400 | Twist Sterile Female Intermittent Catheter, Straight Tip |
| 20815947020394 | Twist Sterile Female Intermittent Catheter, Straight Tip |
| 20815947020387 | Twist Sterile Female Intermittent Catheter, Straight Tip |
| 20815947020370 | Twist Sterile Female Intermittent Catheter, Straight Tip |
| 00815947020369 | Twist Sterile Female Intermittent Catheter, Straight Tip |
Trademark Results [Cure Twist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CURE TWIST 85529741 4321921 Live/Registered |
Cure Medical LLC 2012-01-31 |
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