Primary Device ID | 00690103045734 |
NIH Device Record Key | 9ac07d35-3133-474e-bf42-79d9086f18e4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FOGARTY SOFTJAW |
Version Model Number | SOFT61 |
Catalog Number | SOFT61 |
Company DUNS | 134139174 |
Company Name | Edwards Lifesciences LLC |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE. |
Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00690103045734 [Primary] |
GS1 | 70690103045733 [Unit of Use] |
DXC | CLAMP, VASCULAR |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-03 |
00690103045741 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS |
00690103045734 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS |
00690103045727 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS |
00690103044621 | LIGHTWEIGHT CLIPS AND CLAMPS |
00690103044614 | CLAMP,EDSLAB HANDLELESS 8MM DBLE SOFTJAW |
00690103044317 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS |
00690103044300 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS |
00690103044294 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS |
00690103044195 | FOGARTY SPRING CLIPS 6MM |
00690103044188 | FOGARTY SPRING CLIPS 12MM |