LOBO
GUDID 00850008222009
LOBO Handpiece
OKAMI MEDICAL, INC.
Non-neurovascular embolization plug, metallic| Primary Device ID | 00850008222009 |
| NIH Device Record Key | 42abc9de-ae38-4dcc-94cc-1a99a8b33c8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOBO |
| Version Model Number | LOBO-HP |
| Company DUNS | 117045423 |
| Company Name | OKAMI MEDICAL, INC. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850008222009 [Primary] |
| GS1 | 00850008222023 [Package] Package: carton [5 Units] In Commercial Distribution |
| GS1 | 00850008222047 [Package] Package: carton [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192083
FDA Product Code
| KRD | Device, Vascular, For Promoting Embolization |
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 | 2020-01-15 |
| Device Publish Date | 2020-01-07 |
On-Brand Devices [LOBO]
| 00850008222016 | Peripheral Vascular Occluder |
| 00850008222009 | LOBO Handpiece |
| 00850008222054 | Peripheral Vascular Occluder |
| 00850008222061 | Peripheral Vascular Occluder |
| 00850008222030 | Peripheral Vascular Occluder |
Trademark Results [LOBO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOBO 98881727 not registered Live/Pending |
Lobo EV Technologies Ltd. 2024-12-02 |
 LOBO 98881710 not registered Live/Pending |
Lobo EV Technologies Ltd. 2024-12-02 |
 LOBO 98747922 not registered Live/Pending |
ELEVATED DECK SYSTEMS, INC. 2024-09-12 |
 LOBO 98108765 not registered Live/Pending |
Kind Distribution LLC 2023-07-31 |
 LOBO 98002254 not registered Live/Pending |
Pixel and Shovel, LLC 2023-05-18 |
 LOBO 97134413 not registered Live/Pending |
Sod Solutions, Inc. 2021-11-19 |
 LOBO 88724231 not registered Live/Pending |
Tiki Bar LLC 2019-12-12 |
 LOBO 88715180 not registered Live/Pending |
Alliance Trading, Inc. 2019-12-04 |
 LOBO 88145552 5756849 Live/Registered |
Expo Import 2018-10-06 |
 LOBO 88016834 not registered Live/Pending |
Lobo Strategy Holdings, LLC 2018-06-27 |
 LOBO 87366991 not registered Live/Pending |
OKAMI MEDICAL INC. 2017-03-10 |
 LOBO 87350289 not registered Live/Pending |
CKL Holdings N.V. 2017-02-27 |
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