Folysil AA6108
GUDID 03600040996522
Coloplast A/S
Indwelling urethral drainage balloon catheter, non-antimicrobial| Primary Device ID | 03600040996522 |
| NIH Device Record Key | 86e932e2-f1e0-4d53-b798-52d554bb6262 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Folysil |
| Version Model Number | AA6108 |
| Catalog Number | AA6108 |
| 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
| 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
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03600040995587 [Primary] |
| GS1 | 03600040996058 [Package] Contains: 03600040995587 Package: Retail Box [5 Units] In Commercial Distribution |
| GS1 | 03600040996522 [Package] Contains: 03600040996058 Package: Shipper Box [27 Units] In Commercial Distribution |
FDA Product Code
| EZL | CATHETER, RETENTION TYPE, BALLOON |
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 | 2024-07-22 |
| Device Publish Date | 2024-07-12 |
On-Brand Devices [Folysil]
| 03600040996508 | AA6C24 |
| 03600040996492 | AA6C22 |
| 03600040996485 | AA6C20 |
| 03600040996478 | AA6C18 |
| 03600040996935 | AA6624 |
| 03600040996454 | AA6622 |
| 03600040996447 | AA6620 |
| 03600040996904 | AA6618 |
| 03600040996423 | AA6616 |
| 03600040996416 | AA6614 |
| 03600040996874 | AA6612 |
| 03600040996393 | AA6524 |
| 03600040996850 | AA6522 |
| 03600040996379 | AA6520 |
| 03600040996836 | AA6518 |
| 03600040996355 | AA6516 |
| 03600040996812 | AA6514 |
| 03600040996805 | AA6512 |
| 03600040996324 | AA6424 |
| 03600040996317 | AA6422 |
| 03600040996300 | AA6420 |
| 03600040996294 | AA6418 |
| 03600040996287 | AA6416 |
| 03600040996744 | AA6414 |
| 03600040996263 | AA6412 |
| 03600040996256 | AA6410 |
| 03600040996249 | AA6408 |
| 03600040996232 | AA6406 |
| 03600040996690 | AA6324 |
| 03600040996218 | AA6322 |
| 03600040996201 | AA6320 |
| 03600040996669 | AA6318 |
| 03600040996188 | AA6316 |
| 03600040996645 | AA6314 |
| 03600040996164 | AA6312 |
| 03600040996157 | AA6310 |
| 03600040996614 | AA6308 |
| 03600040996607 | AA6124 |
| 03600040996126 | AA6122 |
| 03600040996119 | AA6120 |
| 03600040996577 | AA6118 |
| 03600040996096 | AA6116 |
| 03600040996089 | AA6114 |
| 03600040996072 | AA6112 |
| 03600040996065 | AA6110 |
| 03600040996522 | AA6108 |
| 03600040996041 | AA6106 |
Trademark Results [Folysil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FOLYSIL 73709418 1510009 Live/Registered |
SYNTHELABO 1988-02-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.