Primary Device ID | 03600040996065 |
NIH Device Record Key | 84061e5e-51e0-4f70-b9da-7a10814fac73 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Folysil |
Version Model Number | AA6110 |
Catalog Number | AA6110 |
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 |
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 |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
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 Issuing Agency | Device ID |
---|---|
GS1 | 03600040995594 [Primary] |
GS1 | 03600040996065 [Package] Contains: 03600040995594 Package: Retail Box [5 Units] In Commercial Distribution |
GS1 | 03600040996539 [Package] Package: Shipper Box [27 Units] In Commercial Distribution |
EZL | CATHETER, RETENTION TYPE, BALLOON |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-22 |
Device Publish Date | 2024-07-12 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FOLYSIL 73709418 1510009 Live/Registered |
SYNTHELABO 1988-02-04 |