Primary Device ID | 00850052601225 |
NIH Device Record Key | ccb7f1a8-0b4c-4938-8e37-a6fbbb25287d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Orca Xtreme ™ Kit Knotless Button |
Version Model Number | AB-6925 |
Catalog Number | AB-6900 |
Company DUNS | 079471560 |
Company Name | DUNAMIS MEDICAL, LLC |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850052601225 [Primary] |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-22 |
Device Publish Date | 2024-03-14 |
00850052601225 - Orca Xtreme ™ Kit Knotless Button | 2024-03-22Orca Xtreme™ Kit Knotless Button |
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™ |
00850052601195 - Fixation Button-Oblong | 2024-02-08 Fixation Button-Oblong |
20854629006912 - Orca™ Mini Knotless Button | 2024-02-08 Orca™ Mini Knotless Button |
30854629006919 - Orca™ XL Knotless Tendon Repair | 2024-02-08 Orca™ XL Knotless Tendon Repair |
40854629006916 - Orca™ Xtreme Knotless Button | 2024-02-08 Orca™ Xtreme Knotless Button |
00850052601041 - Suture Passer - Single Loop | 2023-08-25 Suture Passer - Single Loop |
00854629006321 - 5.5mm PunchTac™ Threaded Anchor PEEK | 2023-08-25 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm Fiber Connect (UHMWPE) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORCA XTREME 97938630 not registered Live/Pending |
Dunamis Medical Technologies, LLC 2023-05-16 |