| Primary Device ID | 04961333242870 |
| NIH Device Record Key | 1d10b616-6e04-4216-af7c-0c25201925cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | DSD-110-HU0109 |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, INC. |
| 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 | 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 | 04961333242870 [Primary] |
| FEB | Accessories, Cleaning, For Endoscope |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
[04961333242870]
High-level Disinfectant
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-03-10 |
| 04961333245406 | v4.0 CSL WIN10 UPGRADE |
| 04961333245314 | MS SQL ENT - 8 CORE LIC (RUNTIME) |
| 04961333245307 | MS SQL ENT - 4 CORE LIC (RUNTIME) |
| 04961333245291 | STANDALONE IMAGE CAPTURE PC |
| 04961333245284 | KEYBOARD FOR EPK-3000 |
| 04961333245277 | CBL,DVID-DVID,6 |
| 04961333245260 | CBL,3.5ST-3.5ST,5,EPK-3000 |
| 04961333245253 | CBL,RGB,9DM-4BNC,5,EPK-3000 |
| 04961333245246 | CBL,BNC-BNC,6, EPK-3000 |
| 04961333245239 | FOOTSWITCH, EPK-3000 |
| 04961333245222 | LAMP FOR EPK-3000 |
| 04961333245215 | FORCEPS TOOTHEDCUP,1.8DIA 60L |
| 04961333245192 | MIC PRE-AMP KIT (ROLLS MP-13) |
| 04961333245185 | DEMO CASE FOR POLE STAND |
| 04961333245178 | DEMO CASE FOR SCOPE, PROCESSOR & MONITOR |
| 04961333244706 | MS SQL STD SINGLE USER LICENSE |
| 04961333244447 | SCOPE PROCESSOR/MONITOR INTEGRATION PKG |
| 04961333244430 | CABLE MANAGEMENT CLIP (5 PACK) |
| 04961333244423 | UP-X898MD B&W VIDEO PRINTER |
| 04961333244416 | FILM PACK B&W 240 PRINTS 897MD 10PC |
| 04961333244409 | FILM PACK 100 PRINTS RIBBON 55MD 2PC |
| 04961333244393 | FILM PACK 200 PRINTS RIBBON 51MDU/D50 |
| 04961333244386 | FILM PACK 50 PRINTS RIBBON 21/20MD 4PC |
| 04961333244348 | POWER STRIP/CABLE CLEAT |
| 04961333244324 | POWER SUPPLY HOLDER/CABLE CLEAT |
| 04961333244317 | TRAY 30.4 CM X 40.6 CM FOR 2"/5 CM POST |
| 04961333244300 | HANDLE FOR 2"/5 CM POST |
| 04961333244294 | UTILITY BASKET |
| 04961333244287 | ADAPTER FOR 70K WITH FWJ |
| 04961333244270 | ADAPTER FOR 70K W/O FWJ |
| 04961333244263 | ADAPTER FOR EB-70K |
| 04961333244256 | CABLE, RGB W/SYNC 6FT. FOR EPK |
| 04961333244249 | CBL,4BNC-4BNC,25 VIDEO |
| 04961333244232 | CBL,4BNC-4BNC,15 VIDEO |
| 04961333244225 | CBL,BNC-BNC,6 VIDEO |
| 04961333244218 | CBL,BNC-BNC,25 VIDEO |
| 04961333244201 | CBL,BNC-BNC,12 VIDEO |
| 04961333244195 | HEAVY DUTY MONITOR POLE STAND |
| 04961333244188 | WATER BOTTLE, REUSABLE |
| 04961333244171 | STANDARD BITE BLOCKS, 3 PIECES |
| 04961333244164 | RUBBER SUCT VALVE 10 PCS DISPO |
| 04961333243990 | MS SQL STD SINGLE SVR & USER LICENSE |
| 04961333243983 | MS SQL STD - 8 CORE LICENSE |
| 04961333243976 | MS SQL STD - 4 CORE LICENSE |
| 04961333243969 | 24" STANDARD MONITOR |
| 04961333243952 | DUAL SCOPE HOLDER TYPE II FOR PREC. CART |
| 04961333243945 | DRAWER, DEEP FOR PREC. CART |
| 04961333243426 | BITE BLOCK 3PCS ST |
| 04961333243419 | SUCTION VALVE, 2 PCS |
| 04961333243402 | VALVE, SUCTION 10 PCS |