FDA.reportPublic FDA data

CoolSeal™ Generator

Primary DI
00850346007023
Brand
CoolSeal™ Generator
Company
JUSTRIGHT SURGICAL, LLC
Model
CSL-200-50
Catalog number
CSL-200-50
Device description
Electrosurgical Generator
Published
2020-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202114000CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20Bolder Surgical, LLC2020-10-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850346007023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850346007023008503460070238503460070230850346007023

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)683-1743info@boldsurg.com
+1(800)442-9892customersupport@hologic.com

Regulatory Flags#

DUNS number
025214641
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865163000102JustRight 5mm StaplerJR-ST25-2.0JR-ST25-2.02015-08-10
00865163000119JustRight5mm ReloadJR-REL25-2.0JR-REL25-2.02015-08-10
00850346007016JustRight 5mm Retrieval bag, 125mlJR-125 ECO-10JR-125 ECO-102016-11-18
00865163000126JustRight SealerJR-SE20JR-SE202015-08-10
00865163000133JustRight GeneratorJR100JR1002015-08-10
10850346007037CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
10850346007044CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
10850346007068CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
10850346007099CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
10865163000109JustRight 5mm StaplerJR-ST25-2.0JR-ST25-2.02015-08-10
10865163000116JustRight5mm ReloadJR-REL25-2.0JR-REL25-2.02015-08-10
10865163000123JustRight SealerJR-SE20JR-SE202015-08-10
10850346007006JustRight 5mm Retrieval bag, 60mlJR-60 ECO-10JR-60 ECO-102016-11-18
10850346007013JustRight 5mm Retrieval bag, 125mlJR-125 ECO-10JR-125 ECO-102016-11-18

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