SOLOMED Disposable Surgical Gown

Basic Information

• Brand Name: SOLOMED Disposable Surgical Gown
• Primary DI: 07502286510059
• Version / Model: Large Size
• Company Name: Solomed, S.A. de C.V.
• Labeler DUNS: 588625921
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 3
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 95d93a5c-33a1-48e2-9183-8478caa30823

Device Description

Disposable surgical gown with adjustable sleeves and cuffs, and chest gusset

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEA	Non-Surgical Isolation Gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35091	Surgical gown, single-use	A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17502286510056	GS1	case	100	In Commercial Distribution
Primary	07502286510059	GS1