Primary Device ID | 04961333244584 |
NIH Device Record Key | d6da8ffb-788c-49f7-b8fd-792ec8572df3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VIDEO GASTROSCOPE |
Version Model Number | EG27-V10C |
Company DUNS | 083211284 |
Company Name | PENTAX OF AMERICA, 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 | false |
Serial Number | true |
Manufacturing Date | false |
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 | 04961333244584 [Primary] |
FDS | Gastroscope And Accessories, Flexible/Rigid |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
[04961333244584]
Ethylene Oxide;High-level Disinfectant
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-04-26 |
Device Publish Date | 2018-03-26 |
04961333244683 | VIDEO GASTROSCOPE - PTAH |
04961333244676 | VIDEO GASTROSCOPE - PTAH |
04961333244591 | VIDEO GASTROSCOPE - PTAH (USED) |
04961333244584 | VIDEO GASTROSCOPE - PTAH (USED) |
04961333242917 | VIDEO GASTROSCOPE |
04961333240173 | VIDEO GASTROSCOPE (USED) |
04961333240166 | VIDEO GASTROSCOPE VERSION-C (USED) |
04961333240159 | VIDEO GASTROSCOPE (USED) |
04961333232574 | VIDEO GASTROSCOPE 3.8C 2.8C 12.8T FWJ (REFURBISHED) |
04961333232543 | VIDEO GASTROSCOPE 3.8C 11.6T 1050L FWJ (REFURBISHED) |
04961333232536 | VIDEO GASTROSCOPE - I10 STANDARD (REFURBISHED) |
04961333232529 | VIDEO GASTROSCOPE 2.8C 9.8T 1050L (REFURBISHED) |
04961333232512 | HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L (REFURBISHED) |
04961333232505 | VIDEO GASTROSCOPE (REFURBISHED) |
04961333232499 | VIDEO GASTROSCOPE (REFURBISHED) |
04961333232482 | VIDEO GASTROSCOPE - I10 SLIM (REFURBISHED) |
04961333232475 | VIDEO GASTROSCOPE 2.8C 9.0T 1050L (REFURBISHED) |
04961333232468 | HD VIDEO GASTROSCOPE 2.8C 9.0T 1050L (REFURBISHED) |
04961333232451 | VIDEO GASTROSCOPE 2.4C 8.0T 1050L (REFURBISHED) |
04961333232444 | VIDEO GASTROSCOPE 2.0C 5.4T 1050L (REFURBISHED) |