Primary Device ID | 00854629006857 |
NIH Device Record Key | df5f5271-93c3-4558-bce6-983208ac40a7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fastloop™ Green |
Version Model Number | DFX24SLG |
Company DUNS | 079471560 |
Company Name | DUNAMIS MEDICAL, LLC |
Device Count | 12 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com | |
Phone | 877.454.2186 |
info@dunamismedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854629006857 [Unit of Use] |
GS1 | 10854629006854 [Primary] |
GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-11 |
Device Publish Date | 2022-03-03 |
00850052601256 - Micro Constrictor ®X Repair Kit | 2024-09-27 Micro Constrictor ® X Repair Kit |
00850052601263 - Constrictor® Mini 2.0 Syndesmosis Repair Kit | 2024-09-27 Constrictor® Mini 2.0 Syndesmosis Repair Kit |
00850052601270 - Constrictor® 2.0 Syndesmosis Repair Kit | 2024-09-27 Constrictor® 2.0Syndesmosis Repair Kit |
00854629006789 - Constrictor® Mini Syndesmosis Repair Kit | 2024-09-27 Constrictor® Mini Syndesmosis Repair 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FASTLOOP 90905400 not registered Live/Pending |
Dunamis Medical Technologies, LLC 2021-08-26 |