Primary Device ID | 00821925002593 |
NIH Device Record Key | 84e7e9e3-e08c-49f7-9a4d-2ae42864e538 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bulb For Ellik Evacuator Latex |
Version Model Number | 194-2 |
Company DUNS | 007198742 |
Company Name | Gyrus Acmi, Inc. |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821925002593 [Primary] |
KQT | EVACUATOR, GASTRO-UROLOGY |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
[00821925002593]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-10-11 |
00810008180983 - nCare | 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG |
00810008180990 - nCare | 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG |
00810008180501 - nCare | 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg |
00810008180921 - nCare | 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg |
00810008180952 - nCare | 2023-09-25 nCare, SNGL,DRCT SDI,DICOM |
00810008180969 - nCare | 2023-09-25 nCare, SNGL, ELA, DICOM |
00810008180976 - nCare | 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG |
00821925036406 - USA Elite | 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm) |