X-Ray Gown

Basic Information

• Brand Name: X-Ray Gown
• Primary DI: 00634916819526
• Version / Model: 74512489
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2021-12-10
• Public Version: 1
• Public Version Date: 2021-12-22
• Public Version Status: New
• Public Device Record Key: c1cf2d9d-af1e-4d8a-9f92-e95646ea52c6

Device Description

X-Ray Gown, 100% spun poly, Burgundy, Size Large, Front Opening

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FME	Gown, Examination	General Hospital	880.6265	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11905	Patient gown, reusable	A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10634916819523	GS1
Primary	00634916819526	GS1

Customer Contacts

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