SureCath 28029
GUDID 05708932640428
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 16/5.3 mm. Vol 1200
Coloplast A/S
Single-administration urethral catheterization kit, single-use| Primary Device ID | 05708932640428 |
| NIH Device Record Key | 036f985d-db61-4dc0-8b4a-7d46f3060615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureCath |
| Version Model Number | 28029 |
| Catalog Number | 28029 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com |
Device Dimensions
| Outer Diameter | 5.3 Millimeter |
| Catheter Gauge | 16 French |
| Total Volume | 1200 Milliliter |
| Device Size Text, specify | 0 |
| Length | 40 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if sterile barrier is damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932021135 [Primary] |
| GS1 | 05708932640428 [Package] Contains: 05708932021135 Package: Shipper box [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K973070
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-02 |
On-Brand Devices [SureCath]
| 05708932640633 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640640 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640671 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640664 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932615884 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640619 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640596 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640343 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640336 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639835 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640428 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640411 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640404 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640381 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640367 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932640350 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639828 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639804 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639798 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639781 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639774 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
| 05708932639767 | SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic |
Trademark Results [SureCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURECATH 75767233 2476472 Live/Registered |
Coloplast A/S 1999-08-03 |
 SURECATH 73673722 1574606 Dead/Cancelled |
TITAN MEDICAL INC. 1987-07-22 |
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