| Primary Device ID | 05708932767545 |
| NIH Device Record Key | 884ab3ce-6d3b-4be2-a572-afe13dd5b620 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insertion Tool |
| Version Model Number | NTER01 |
| Catalog Number | NTER01 |
| Company DUNS | 847436391 |
| Company Name | COLOPLAST CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| 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 | |
| Phone | +1(800)258-3476 |
| urology@coloplast.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932767521 [Primary] |
| GS1 | 05708932767538 [Package] Contains: 05708932767521 Package: Retail Box [35 Units] In Commercial Distribution |
| GS1 | 05708932767545 [Package] Contains: 05708932767538 Package: Shipper Box [8 Units] In Commercial Distribution |
| KGZ | ACCESSORIES, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-07 |
| Device Publish Date | 2024-09-27 |
| 05708932767545 - Insertion Tool | 2024-10-07 |
| 05708932767545 - Insertion Tool | 2024-10-07 |
| 00311701068726 - InterDry | 2021-04-19 InterDry. Moisture Wicking Fabric with Antimicrobial Silver. 144 in by 10 in |
| 00311701069426 - InterDry | 2021-04-19 InterDry. Moisture Wicking Fabric with Antimicrobial Silver. 36 in by 10 in. |
| 00311701069938 - InterDry | 2021-04-19 InterDry. Moisture Wicking Fabric with Antimicrobial Silver. 18 in by 10 in. |