Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10193489085358
• Version / Model: ESSHROUD10
• Catalog Number: ESSHROUD10
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-22
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: fdc679ae-1a81-42db-898c-503e47170ad6

Device Description

SHROUD, ATTACHMENT, SMOKE EVAC, 10'

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: 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
FYD	APPARATUS, EXHAUST, SURGICAL	General, Plastic Surgery	878.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11490	Electrosurgical system generator	An electrically-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 inert gas-enhanced electrosurgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20193489085355	GS1	CASE	20	In Commercial Distribution
Primary	10193489085358	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, cool and dry place. Handle with care to avoid damage to the packaging and its content during transportation and storage.