Sureglide

Basic Information

• Brand Name: Sureglide
• Primary DI: 00855009006092
• Version / Model: ECO158005
• Catalog Number: ECO158005
• Company Name: ECOMED SOLUTIONS, LLC
• Labeler DUNS: 079814353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-21
• Public Version: 3
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: dea41850-945d-44e3-86d7-53279ab14f81

Device Description

Sureglide Safety Scalpel

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
GDX	Scalpel, One-Piece	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855009006092	GS1
Package	10855009006099	GS1	Inner Pack	10	In Commercial Distribution
Package	20855009006096	GS1	Case	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Surgical Blade #11

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry