Primary Device ID | GYNXCMR25101 |
NIH Device Record Key | c02c37d8-99f3-45da-8953-0acfeb3def0b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Carrera Loop Electrodes |
Version Model Number | CMR-2510 |
Company DUNS | 012997685 |
Company Name | GYNEX CORPORATION |
Device Count | 5 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | GYNXCMR25100 [Unit of Use] |
HIBCC | GYNXCMR25101 [Primary] |
HGI | Electrocautery, Gynecologic (And 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 | 2016-10-04 |
GYNXOCMR25151 | OCMR-2515 |
GYNXOCMR25101 | OCMR-2510 |
GYNXOCMR20151 | OCMR-2015 |
GYNXOCMR20131 | OCMR-2013 |
GYNXOCMR20101 | OCMR-2010 |
GYNXOCMR20081 | OCMR-2008 |
GYNXOCMR15121 | OCMR-1512 |
GYNXOCMR10101 | OCMR-1010 |
GYNXCMR25151 | CMR-2515 |
GYNXCMR25101 | CMR-2510 |
GYNXCMR20151 | CMR-2015 |
GYNXCMR20131 | CMR-2013 |
GYNXCMR20101 | CMR-2010 |
GYNXCMR20081 | CMR-2008 |
GYNXCMR15121 | CMR-1512 |
GYNXCMR15081 | CMR-1508 |
GYNXCMR10101 | CMR-1010 |
GYNXCMR10071 | CMR-1007 |
GYNXCMB2521 | CMB-2-5-2 |