Enseal

Basic Information

• Brand Name: Enseal
• Primary DI: 10705036000037
• Version / Model: NSEAL525RH
• Catalog Number: NSEAL525RH
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 3
• Public Version Date: 2019-10-16
• Public Version Status: Update
• Public Device Record Key: 3c583a5f-298b-4f6c-81a2-d5b07881dc77

Device Description

Enseal Temperature Controlled Tissue Sealing Technology Disposable Tissue Sealing Device Taptronic Trigger Activated Power 5mm Jaw Style

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705036000037	GS1
Package	20705036000034	GS1	BOX	6	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, Dry place
• Type: Storage Environment Temperature
• Temperature Range: -22 – 60 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity