Primary Device ID | 00850052601232 |
NIH Device Record Key | 8e622eb3-d366-4060-88dc-68a9a93a4727 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Micro Constrictor® Implantation Kit |
Version Model Number | AB-8250 |
Catalog Number | AB-6950 |
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 | 00850052601232 [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 | 2024-06-18 |
Device Publish Date | 2024-06-10 |
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 | 2024-06-18Micro Constrictor® Implantation Kit |
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™ |