BoNee NBI035
GUDID 03600040974858
Coloplast A/S
General-purpose endoscopic needle, single-use| Primary Device ID | 03600040974858 |
| NIH Device Record Key | e18cfbf2-917b-45e5-8fb6-79dac030f240 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BoNee |
| Version Model Number | NBI035 |
| Catalog Number | NBI035 |
| 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
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 French |
| Length | 35 Centimeter |
| Catheter Gauge | 5 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 | 03600040974841 [Primary] |
| GS1 | 03600040974858 [Package] Contains: 03600040974841 Package: Retail Box [1 Units] In Commercial Distribution |
| GS1 | 03600040974865 [Package] Package: Shipper Box [54 Units] In Commercial Distribution |
FDA Product Code
| FBK | endoscopic injection needle, gastroenterology-urology |
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 | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
On-Brand Devices [BoNee]
| 03600040974858 | NBI035 |
| 03600040974919 | NBI070 |
Trademark Results [BoNee]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BONEE 79033020 3389165 Live/Registered |
Coloplast A/S 2006-11-22 |
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