Primary Device ID | 14897106954107 |
NIH Device Record Key | bf61959a-79de-4372-8783-56013ebd6537 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | STOPCON Biopsy Valve For Pentax® GI-Endoscope |
Version Model Number | EN10234B |
Company DUNS | 686908512 |
Company Name | GA Health Company Limited |
Device Count | 1 |
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 | true |
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 | 04897106954100 [Primary] |
GS1 | 14897106954107 [Package] Contains: 04897106954100 Package: Box [100 Units] In Commercial Distribution |
GS1 | 24897106954104 [Package] Package: Carton [4 Units] In Commercial Distribution |
ODC | Endoscope Channel Accessory |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-08 |
Device Publish Date | 2022-01-31 |