Self-Cath 50523
GUDID 05708932279963
Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 14. 16 in. 40 cm. Rx only.
Coloplast A/S
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 | 05708932279963 |
| NIH Device Record Key | f352a9ee-7e7d-4f51-a03d-13fb239a88f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Self-Cath |
| Version Model Number | 50523 |
| Catalog Number | 50523 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Catheter Gauge | 14 French |
| Length | 16 Inch |
| Length | 40 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 14.9 Inch |
| Catheter Working Length | 38 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult IFU. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932279956 [Package] Contains: 05708932575898 Package: Retail box [30 Units] In Commercial Distribution |
| GS1 | 05708932279963 [Package] Contains: 05708932279956 Package: Shipper box [12 Units] In Commercial Distribution |
| GS1 | 05708932575898 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003784
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 [Self-Cath]
| 05708932277235 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Luer End. Pediatric. FR 8. 10 in. 25 cm. Rx |
| 05708932277242 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Luer End. Pediatric. FR 10. 10 in. 25 cm. |
| 05708932277204 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Pediatric. FR 6. 10 in. 25 cm |
| 05708932279055 | Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe. Male. FR 10. 16 in. 40 cm. Rx only. |
| 05708932278881 | Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe. Male. FR 8. 16 in. 40 cm. Rx only |
| 05708932288743 | Self-Cath. Urinary Catheter. Straight Tip. Female. FR 8. 6 in. 16 cm. Rx only. |
| 05708932279697 | Self-Cath Plus. Hydrophilic-coated Soft Straight Tip. Male. FR 10. 16 in. 40 cm. Rx only. |
| 05708932279727 | Self-Cath Plus. Hydrophilic-coated Soft Straight Tip. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932279116 | Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe. Male. FR 18. 16 in. 40 cm. Rx only. |
| 05708932278935 | Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe. Male. FR 12. 16 in. 40 cm. Rx onl |
| 05708932278775 | Self-Cath. Urinary Catheter. Straight Tip. Male. FR 18. 16 in. 40 cm. Rx only. |
| 05708932278553 | Self-Cath. Urinary Catheter. Soft Straight Tip. Male. FR 14. 16 in. 40 cm. Rx only. |
| 05708932288736 | Self-Cath. Urinary Catheter. Soft Straight Tip. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932278607 | Self-Cath. Urinary Catheter. Straight Tip. Female. FR 10. 6 in. 16 cm. Rx only. |
| 05708932278812 | Self-Cath. Urinary Catheter. Long Straight Tip. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932278799 | Self-Cath. Urinary Catheter. Long Straight Tip. Male. FR 14. 16 in. 40 cm. Rx only. |
| 05708932278720 | Self-Cath. Urinary Catheter. Straight Tip. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932278744 | Self-Cath. Urinary Catheter. Straight Tip. Male. FR 14. 16 in. 40 cm. Rx only. |
| 05708932278690 | Self-Cath. Urinary Catheter. Straight Tip. Male. FR 8. 16 in. 40 cm. Rx only. |
| 05708932282819 | Self-Cath. Urinary Catheter. Straight Tip. Pediatric. FR 6. 10 in. 25 cm. Rx only. |
| 05708932282802 | Self-Cath. Urinary Catheter. Straight Tip. Pediatric. FR 5. 10 in. 25 cm. Rx only. |
| 05708932279963 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 14 |
| 05708932279857 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR |
| 05708932277297 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 10. 16 in. 40 cm. Rx |
| 05708932279093 | Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe. Male. FR 16. 16 in. 40 cm. Rx only. |
| 05708932279079 | Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932278577 | Self-Cath. Urinary Catheter. Soft Straight Tip. Male. FR 16. 16 in. 40 cm. Rx only. |
| 05708932279772 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 16. 16 in. 40 cm. Rx |
| 05708932277310 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 12. 16 in. 40 cm. Rx |
| 05708932277266 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 8. 16 in. 40 cm. Rx |
| 05708932279765 | Self-Cath Plus. Hydrophilic-coated Soft Straight Tip. Male. FR 16. 16 in. 40 cm. Rx only. |
| 05708932279741 | Self-Cath Plus. Hydrophilic-coated Soft Straight Tip. Male. FR 14. 16 in. 40 cm. Rx only. |
| 05708932282796 | Self-Cath. Urinary Catheter. Straight Tip without connector. Female. FR 14. 6 in. 16 cm. Rx only |
| 05708932277198 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Female. FR 14. 6 in. 16 cm. R |
| 05708932277167 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Female. FR 12. 6 in. 16 cm. R |
| 05708932277327 | Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 14. 16 in. 40 cm. Rx |
| 05708932282826 | Self-Cath. Urinary Catheter. Luer End. Pediatric. FR 8. 10 in. 25 cm. Rx only. |
| 05708932278522 | Self-Cath. Urinary Catheter. Soft Straight Tip. Male. FR 10. 16 in. 40 cm. Rx only. |
| 05708932465069 | Self-Cath Urinary Catheter. Straight tip. Female. FR 12. 6 in. 16 cm. Rx only. |
| 05708932465090 | Self-Cath Urinary Catheter. Straight tip. Female. FR 14. 6 in. 16 cm. Rx only. |
| 05708932465106 | Self-Cath Urinary Catheter. Straight tip. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932465120 | Self-Cath Urinary Catheter. Straight tip. Male. FR 14 . 16 in. 40 cm. Rx only. |
| 05708932465670 | Self-Cath Urinary Catheter. Long Straight Tip. Male. FR 14. 16 in. 40 cm. Rx only. |
| 05708932465656 | Self-Cath Urinary Catheter. Long Straight Tip. Male. FR 12. 16 in. 40 cm. Rx only. |
| 05708932441599 | Self-Cath Urinary Catheter. Olive Tip Coude w/Guide Stripe. Male. FR 16. 16 in. 40 cm. Rx only. |
| 05708932441568 | Self-Cath Urinary Catheter. Tapered Tip Coude w/Guide Stripe. Male. FR 14. 16 in. 40 cm. Rx only |
| 05708932441520 | Self-Cath Urinary Catheter. Olive Tip Coude w/Guide Stripe. Male. FR 14. 16 in. 40 cm. Rx only. |
| 05708932441506 | Self-Cath Urinary Catheter. Straight tip. Male. FR 16. 16 in. 40 cm. Rx only. |
| 05708932735353 | Self-Cath®. Urinary Catheter. Straight Tip Male . Catheter Gauge 18 FR/CH, Diameter 6.0 mm. |
| 05708932735339 | Self-Cath®. Urinary Catheter. Soft Straight Tip Male. Catheter Gauge 12 FR/CH, Diameter 4.0 mm. |
Trademark Results [Self-Cath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SELF-CATH 73135423 1092225 Live/Registered |
MENTOR CORPORATION 1977-07-27 |
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