Cure Catheter®
GUDID 00815947020000
Sterile Intermittent Urinary Catheter with Funnel End, 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 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 | 00815947020000 |
| NIH Device Record Key | bb17b0ea-1fe4-4f96-a2dd-01ed9a7e24f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cure Catheter® |
| Version Model Number | M8 |
| 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 | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| 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 |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
| Catheter Gauge | 8 French |
| Length | 41 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815947020000 [Primary] |
| GS1 | 10815947020007 [Package] Package: Box [30 Units] In Commercial Distribution |
| GS1 | 20815947020004 [Package] Contains: 10815947020007 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072539
FDA Product Code
| EZD | Catheter, Straight |
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 Catheter®]
| 20815947021223 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947021216 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947021025 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947021018 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947021001 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020998 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020981 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020509 | Sterile Intermittent Catheter, Hydrophilic Coated with water packet and gripper plus insertion k |
| 00815947020499 | Sterile Intermittent Catheter with Insertion Kit, Straight Tip |
| 20815947020486 | Sterile Intermittent Catheter with Lubricant Packet, Straight Tip |
| 20815947020356 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020349 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 00815947020338 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020325 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020318 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020301 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and |
| 20815947020295 | Sterile Pediatric Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020288 | Sterile Pediatric Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020271 | Sterile Pediatric Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020264 | Sterile Pediatric Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020257 | Sterile Pediatric Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020240 | Sterile Female Intermittent Urinary Catheter, Straight Tip |
| 20815947020233 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020226 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020219 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020202 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020196 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020189 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020134 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020127 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020110 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020103 | Sterile Intermittent Urinary Catheter with Funnel End, Coudé Tip |
| 20815947020097 | Sterile Intermittent Urinary Catheter with Funnel End, Coudé Tip |
| 20815947020080 | Sterile Intermittent Urinary Catheter with Funnel End, Coudé Tip |
| 20815947020073 | Sterile Intermittent Urinary Catheter with Funnel End, Coudé Tip |
| 20815947020066 | Sterile Intermittent Urinary Catheter with Funnel End, Coudé Tip |
| 20815947020059 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020042 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020035 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020028 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 20815947020011 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
| 00815947020000 | Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip |
Trademark Results [Cure Catheter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CURE CATHETER 86125386 4591923 Live/Registered |
Cure Medical, LLC 2013-11-21 |
 CURE CATHETER 78348044 3110064 Live/Registered |
CURE MEDICAL LLC 2004-01-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.