CoolSeal™ Generator CSL-200-50
GUDID 00850346007023
Electrosurgical Generator
JUSTRIGHT SURGICAL, LLC
Electrosurgical system generator| Primary Device ID | 00850346007023 |
| NIH Device Record Key | e0ea0e61-f0a1-40c3-9edc-365af2f81fae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoolSeal™ Generator |
| Version Model Number | CSL-200-50 |
| Catalog Number | CSL-200-50 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(866)683-1743 |
| info@boldsurg.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com | |
| Phone | +1(800)442-9892 |
| customersupport@hologic.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850346007023 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202114
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2020-10-13 |
Devices Manufactured by JUSTRIGHT SURGICAL, LLC
| 00850346007085 - CoolSeal™ Mini | 2021-05-19 Maryland Laparoscopic Sealer |
| 00850346007023 - CoolSeal™ Generator | 2020-10-21Electrosurgical Generator |
| 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 |
Trademark Results [CoolSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOLSEAL 87880562 not registered Live/Pending |
JustRight Surgical, LLC 2018-04-17 |
 COOLSEAL 79144961 4639094 Live/Registered |
Tri-Pack Plastics Ltd 2014-01-10 |
 COOLSEAL 79048886 3570214 Dead/Cancelled |
Tri-Pack Plastics Ltd 2007-12-19 |
 COOLSEAL 79030822 3436222 Dead/Cancelled |
BLV Licht- und Vakuumtechnik GmbH 2006-10-24 |
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