Titan Classic ES8824
GUDID 05708932768115
Coloplast A/S
Inflatable penile prosthesis| Primary Device ID | 05708932768115 |
| NIH Device Record Key | e3f30da3-36c0-4f16-9372-a7ebd97f7c1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Titan Classic |
| Version Model Number | ES8824 |
| Catalog Number | ES8824 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com |
Device Dimensions
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
| Length | 24 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Do not use if package is damaged and consult IFU. Do not resterilize. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932768115 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P000006
FDA Product Code
| FHW | Device, impotence, mechanical/hydraulic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
On-Brand Devices [Titan Classic]
| 05708932768139 | ES8924 |
| 05708932768115 | ES8824 |
Trademark Results [Titan Classic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TITAN CLASSIC 78327786 not registered Dead/Abandoned |
Warrior Lacrosse, Inc. 2003-11-13 |
 TITAN CLASSIC 78201305 not registered Dead/Abandoned |
Warrior Lacrosse, Inc. 2003-01-08 |
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