| Primary Device ID | 00815947021335 | 
| NIH Device Record Key | 63dfc1af-174f-4f92-9a69-f70afb06ab88 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cure Catheter | 
| Version Model Number | UltraPlus CH08 | 
| Company DUNS | 809784593 | 
| Company Name | CONVATEC, PURCHASING DEPARTMENT | 
| 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 | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 1-800-422-8811 | 
| cic@convatec.com | |
| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
| cic@convatec.com | |
| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
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| Phone | 1-800-422-8811 | 
| cic@convatec.com | |
| Phone | 1-800-422-8811 | 
| cic@convatec.com | |
| Phone | 1-800-422-8811 | 
| cic@convatec.com | |
| Phone | +18004228811 | 
| cic@convatec.com | |
| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
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| Phone | +18004228811 | 
| cic@convatec.com | 
| 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 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00815947021335 [Primary] | 
| GS1 | 10815947021332 [Package] Package: Inner Carton [30 Units] In Commercial Distribution | 
| GS1 | 20815947021339 [Package] Contains: 10815947021332 Package: Shipper [10 Units] In Commercial Distribution | 
| KOD | Catheter, Urological | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-04-27 | 
| Device Publish Date | 2022-04-19 | 
| 10815947021165 | Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and | 
| 00815947021380 | Sterile Female Intermittent Catheter, Straight Tip | 
| 00815947021373 | Sterile Female Intermittent Catheter, Straight Tip | 
| 00815947021366 | Sterile Female Intermittent Catheter, Straight Tip | 
| 00815947021342 | Sterile Female Intermittent Catheter, Straight Tip | 
| 00815947021335 | Sterile Female Intermittent Catheter, Straight Tip | 
| 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 |