Primary Device ID | 04961333240302 |
NIH Device Record Key | 7bb4e99a-d4af-4b3a-a8ac-23ca71aaab0b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FIBER INTUBATION SCOPE |
Version Model Number | FI-16RBS |
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 | true |
Serial Number | false |
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 | 04961333240302 [Primary] |
CAL | Laryngoscope, Non-Rigid |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04961333240302]
Ethylene Oxide;High-level Disinfectant
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-04-12 |
Device Publish Date | 2018-03-12 |
04961333240326 | FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP (USED) |
04961333240319 | FIBEROPTICINTUBATIONSCOPE 2.4TP RO PLS (USED) |
04961333240302 | FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED) |
04961333240296 | FIBEROPTICINTUBATIONSCOPE 1.8C 4.1TP ROP (USED) |
04961333240289 | FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP (USED) |