ComPel MLR Surgical Gown

Basic Information

• Brand Name: ComPel MLR Surgical Gown
• Primary DI: 00634916709674
• Version / Model: 75674395
• Catalog Number: 75674395
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2020-04-03
• Public Version: 4
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 769fbfd7-7cf0-4df4-b268-691f8f9e6265

Device Description

ComPel MLR Surgical Gown, 2-Ply Front, Circumferentially Offset Sleeves, Aqua Compel MLR Outer Sleeves and White Compel MLR with Negastat Inner Sleeves, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Barcode, Overcast Safety Stitch Body Size Large

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYA	Gown, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11902	Surgical gown, reusable	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 reusable garment intended to be laundered after each use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00634916709674	GS1
Unit of Use	10634916709671	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041541	000