Primary Device ID | 00821925003170 |
NIH Device Record Key | c4416dec-d6b5-4c52-a7ba-f318cbe09d63 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | USA Elite System™ Rotating Continuous Flow Resectoscope Visual Obtura |
Version Model Number | ERVO-CF27 |
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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821925003170 [Primary] |
FEC | OBTURATOR, FOR ENDOSCOPE |
HIH | Hysteroscope (And Accessories) |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
Moist Heat or Steam Sterilization
[00821925003170]
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 | 2016-10-14 |
00821925003170 | ERVO-CF27 VISUAL OBTURATOR CF ROT 27FR |
00821925003163 | ERVO-CF25 OBTURATOR ROT CF 25FR |