| Primary Device ID | 04961333244102 |
| NIH Device Record Key | 81f411f1-38de-4aec-b275-735ec1e568c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NDS |
| Version Model Number | NDS90Z0156 |
| 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 | 04961333244102 [Primary] |
| KQM | Camera, Surgical And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2018-03-15 |
| 04961333244539 | NDS 32" LED DISPLAY, W/O FIBER |
| 04961333244522 | RADIANCE 55" G2 LED, W/SINGLE FIBER |
| 04961333244126 | NDS CONDUCTOR G2 BASE UNIT(HD STRM INCL) |
| 04961333244119 | ZWIRE G2 ACC. RADI. ULTRA 27 (SNGL) |
| 04961333244102 | ZWIRE G2 ACC. RADI. ULTRA 27 (PAIR) |
| 04961333244096 | 27" RADIANCE ULTRA MONITOR |
| 04961333244089 | ZEROWIRE G2 PAIR (RX & TX) |
| 04961333244072 | NDS RADIANCE ULTRA 32" ANALOG MONITOR |
| 04961333244065 | 42" RADIANCE G2 LED WITH SINGLE FIBER |
| 04961333244058 | RADIANCE 24" G2 W/SINGLE FIBER |
| 04961333244041 | NDS 21" ENDOVUE DISPLAY |
| 04961333244034 | NDS 21" ENDOVUE DISPLAY |
| 04961333244027 | NATIONAL DISPLAY 26" RADIANCE HD LED MON |
| 04961333244010 | NDS 24" LED MONITOR |
| 04961333244003 | NDS 24" ENDOVUE MONITOR |
| 04961333243280 | NDS CONDUCTOR VIDEO SWITCHING PACKAGE |
| 04961333240906 | NDS 19IN RADIANCE HD MONITOR MED GRADE |
| 04961333240739 | POWER SUPPLY-NDS 23" AND 32" MONITOR |
| 04961333240722 | POWER SUPPLY- NDS 26" LED MONITOR |