Primary Device ID | 20859729006107 |
NIH Device Record Key | 313cc2b0-a428-4b4c-b076-4259d4df8595 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FMwand |
Version Model Number | 2101S |
Catalog Number | FM2101S |
Company DUNS | 963249342 |
Company Name | DOMAIN SURGICAL, 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 | true |
Expiration Date | false |
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 | 00859729006103 [Primary] |
GS1 | 10859729006100 [Package] Contains: 00859729006103 Package: Sterile Pouch [1 Units] In Commercial Distribution |
GS1 | 20859729006107 [Package] Contains: 10859729006100 Package: Box [5 Units] In Commercial Distribution |
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-06-10 |
20859729006176 | FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Blade |
20859729006145 | FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 5 mm Resecting Loop |
20859729006138 | FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loop |
20859729006121 | FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade |
20859729006114 | FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 5 mm Resecting Loop |
20859729006107 | FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Loop |
20859729006091 | FMwand Handpiece - 150 mm Length with 5 mm Resecting Loop |
20859729006084 | FMwand Handpiece - 150 mm Length with 2 mm Dissecting Loop |
20859729006077 | FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop |
20859729006060 | FMwand Handpiece - 100 mm Length with 5 mm Resecting Loop |
20859729006053 | FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FMWAND 85213161 4151070 Live/Registered |
Domain Surgical, Inc. 2011-01-07 |