| Primary Device ID | 05056394300108 |
| NIH Device Record Key | c7f19d96-d92f-4c1e-aa0a-c7b16a58e1b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MYO |
| Version Model Number | 7 3/4in Myo Kinisi Myoelectric hand LEFT with NA w |
| Catalog Number | KIN775LNA |
| Company DUNS | 210280350 |
| Company Name | HUGH STEEPER LIMITED |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056394300108 [Primary] |
| IQZ | Hand, External Limb Component, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-12 |
| Device Publish Date | 2023-07-04 |
| 05056394300238 | 8 1/4in Myo Kinisi Myoelectric hand RIGHT with EQD |
| 05056394300221 | 8 1/4in Myo Kinisi Myoelectric hand RIGHT with N A |
| 05056394300214 | 8 1/4in Myo Kinisi Myoelectric hand RIGHT with fri |
| 05056394300191 | 8 1/4in Myo Kinisi Myoelectric hand LEFT with EQD |
| 05056394300184 | 8 1/4in Myo Kinisi Myoelectric hand LEFT with N A |
| 05056394300177 | 8 1/4in Myo Kinisi Myoelectric hand LEFT with fric |
| 05056394300153 | 7 3/4in Myo Kinisi Myoelectric hand RIGHT with EQD |
| 05056394300146 | 7 3/4in Myo Kinisi Myoelectric hand RIGHT with NA |
| 05056394300139 | 7 3/4in Myo Kinisi Myoelectric hand RIGHT with fri |
| 05056394300122 | 7 3/4in Myo Kinisi Myoelectric hand RIGHT with EU |
| 05056394300115 | 7 3/4in Myo Kinisi Myoelectric hand LEFT with EQD |
| 05056394300108 | 7 3/4in Myo Kinisi Myoelectric hand LEFT with NA w |
| 05056394300092 | 7 3/4in Myo Kinisi Myoelectric hand LEFT with fric |
| 05056394300078 | 7 1/4in Myo Kinisi Myoelectric hand RIGHT with EQD |
| 05056394300061 | 7 1/4 Myo Kinisi Myoelectric hand RIGHT with N A w |
| 05056394300054 | 7 1/4in Myo Kinisi Myoelectric hand RIGHT with fri |
| 05056394300030 | 7 1/4in Myo Kinisi Myoelectric hand LEFT with EQD |
| 05056394300023 | 7 1/4 Myo Kinisi Myoelectric hand LEFT with NA wri |
| 05056394300016 | 7 1/4in Myo Kinisi Myoelectric hand LEFT with fric |
| 05056701110253 | BT KINISI 8 1/4 RH EQD WRIST |
| 05056701110246 | BT KINISI 8 1/4 RH NA WRIST |
| 05056701110239 | BT KINISI 8 1/4 RH FW |
| 05056701110222 | BT KINISI 8 1/4 RH EU WRIST |
| 05056701110215 | BT KINISI 8 1/4 LH EQD WRIST |
| 05056701110208 | BT KINISI 8 1/4 LH NA WRIST |
| 05056701110192 | BT KINISI 8 1/4 LH FW |
| 05056701110185 | BT KINISI 8 1/4 LH EU WRIST |
| 05056701110178 | BT KINISI 7 3/4 RH EQD WRIST |
| 05056701110161 | BT KINISI 7 3/4 RH NA WRIST |
| 05056701110154 | BT KINISI 7 3/4 RH FW |
| 05056701110147 | BT KINISI 7 3/4 RH EU WRIST |
| 05056701110130 | BT KINISI 7 3/4 LH EQD WRIST |
| 05056701110123 | BT KINISI 7 3/4 LH NA WRIST |
| 05056701110116 | BT KINISI 7 3/4 LH FW |
| 05056701110109 | BT KINISI 7 3/4 LH EU WRIST |
| 05056701110093 | BT KINISI 7 1/4 RH EQD WRIST |
| 05056701110086 | BT KINISI 7 1/4 RH NA WRIST |
| 05056701110079 | BT KINISI 7 1/4 RH FW |
| 05056701110062 | BT KINISI 7 1/4 RH EU WRIST |
| 05056701110055 | BT KINISI 7 1/4 LH EQD WRIST |
| 05056701110048 | BT KINISI 7 1/4 LH NA WRIST |
| 05056701110031 | BT KINISI 7 1/4 LH FW WRIST |
| 05056701110024 | BT KINISI 7 1/4 LH EU WRIST |
| 05063368216198 | SDU CONE ASSEMBLY |
| 05055348244116 | ON/OFF SWITCH AND CHARGE PORT |
| 05055348202932 | 50MM SH WR HOUSING |
| 05056349591032 | MYO Configuration Device |
| 05055348248312 | Myoelectric Hand Quick Disconnect Wrist 8 1/4 Righ |
| 05055348248305 | Myoelectric Hand Quick Disconnect Wrist 7 3/4 Righ |
| 05055348200075 | Myoelectric Hand Quick Disconnect Wrist 6 3/4" Rig |