| Primary Device ID | 00865163000133 |
| NIH Device Record Key | ab1dc4a1-b021-4772-a72c-159914a77730 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JustRight Generator |
| Version Model Number | JR100 |
| Catalog Number | JR100 |
| Company DUNS | 025214641 |
| Company Name | JUSTRIGHT SURGICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865163000133 [Primary] |
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-10 |
| 00850346007085 - CoolSeal™ Mini | 2021-05-19 Maryland Laparoscopic Sealer |
| 00850346007023 - CoolSeal™ Generator | 2020-10-21 Electrosurgical Generator |
| 10850346007037 - CoolSeal™ Trinity | 2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 30 cm |
| 10850346007044 - CoolSeal™ Trinity | 2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 37 cm |
| 10850346007068 - CoolSeal™ Trinity | 2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 44 cm |
| 10850346007099 - CoolSeal™ Mini | 2020-10-21 Maryland Laparoscopic Sealer |
| 10865163000109 - JustRight 5mm Stapler | 2019-05-07 JustRight 5mm Stapler-single |
| 10865163000116 - JustRight5mm Reload | 2019-05-07 JustRight 5mm Reload - single |