CoolSeal™ Mini

Basic Information

• Brand Name: CoolSeal™ Mini
• Primary DI: 00850346007085
• Version / Model: CSL-MN103-20
• Catalog Number: CSL-MN103-20
• Company Name: JUSTRIGHT SURGICAL, LLC
• Labeler DUNS: 025214641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-13
• Public Version: 5
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: 154f7328-bcc6-4c28-9abc-6128ef497a34

Device Description

Maryland Laparoscopic Sealer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57944	Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850346007085	GS1
Package	10850346007082	GS1	case	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K202114	000

Device Sizes

Type	Value	Unit	Text
Length	20	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 0 – 28 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius