Primary Device ID | 00850052601249 |
NIH Device Record Key | ea3ba834-a755-417d-aa72-1f3214334a24 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Orca™ Implantation Kit |
Version Model Number | AB-6250 |
Catalog Number | AB-6250 |
Company DUNS | 079471560 |
Company Name | DUNAMIS MEDICAL, LLC |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850052601249 [Primary] |
HTW | Bit, Drill |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-28 |
Device Publish Date | 2024-06-20 |
00850052601249 - Orca™ Implantation Kit | 2024-06-28Orca™ Implantation Kit |
00850052601249 - Orca™ Implantation Kit | 2024-06-28 Orca™ Implantation Kit |
00850052601072 - Hallux Guide | 2024-06-18 Hallux Guide |
00850052601089 - CMC Spacer | 2024-06-18 CMC Spacer |
00850052601096 - CMC Guide | 2024-06-18 CMC Guide |
00850052601157 - Threaded Driver | 2024-06-18 Threaded Driver |
00850052601232 - Micro Constrictor® Implantation Kit | 2024-06-18 Micro Constrictor® Implantation Kit |
00850052601225 - Orca Xtreme ™ Kit Knotless Button | 2024-03-22 Orca Xtreme™ Kit Knotless Button |
00850052601188 - Force DFX Suture-Xtreme™ | 2024-02-08 Force DFX Suture-Xtreme™ |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ORCA 98532361 not registered Live/Pending |
Orca Companies, LLC 2024-05-03 |
![]() ORCA 98326575 not registered Live/Pending |
Orca Innovation LLC 2023-12-21 |
![]() ORCA 98326562 not registered Live/Pending |
Orca Innovation LLC 2023-12-21 |
![]() ORCA 98183524 not registered Live/Pending |
Orca Life, LLC 2023-09-17 |
![]() ORCA 98117708 not registered Live/Pending |
Obray Business Ventures, LLC 2023-08-04 |
![]() ORCA 97897107 not registered Live/Pending |
Pride Manufacturing Company, LLC 2023-04-19 |
![]() ORCA 97762783 not registered Live/Pending |
Pride Manufacturing Company, LLC 2023-01-20 |
![]() ORCA 97750146 not registered Live/Pending |
S & F SUPPLIES, INC 2023-01-11 |
![]() ORCA 97656674 not registered Live/Pending |
The Department of the Navy 2022-11-01 |
![]() ORCA 97586923 not registered Live/Pending |
Fauna Bio Incorporated 2022-09-12 |
![]() ORCA 97366857 not registered Live/Pending |
Benator, Max 2022-04-16 |
![]() ORCA 97237992 not registered Live/Pending |
Dunamis Medical Technologies, LLC 2022-01-25 |