CapsoCam Plus 2795
GUDID 00867770000261
Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit
CAPSOVISION, INC.
Video capsule endoscopy system capsule| Primary Device ID | 00867770000261 |
| NIH Device Record Key | f7115e77-03cb-43be-9bc9-db8c6ab58a30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CapsoCam Plus |
| Version Model Number | SV-3KIT |
| Catalog Number | 2795 |
| Company DUNS | 789635740 |
| Company Name | CAPSOVISION, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com | |
| Phone | 408-624-1488 |
| info@capsovision.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867770000209 [Previous] |
| GS1 | 00867770000261 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192662
FDA Product Code
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-12-11 |
On-Brand Devices [CapsoCam Plus]
| 00867770000209 | Small Bowel Capsule Endoscope |
| 00867770000261 | Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit |
Trademark Results [CapsoCam Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSOCAM PLUS 86655586 5205411 Live/Registered |
CapsoVision, Inc. 2015-06-09 |
 CAPSOCAM PLUS 86655575 5167085 Live/Registered |
CapsoVision, Inc. 2015-06-08 |
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