MAMMOGRAPHY GOWN

Basic Information

• Brand Name: MAMMOGRAPHY GOWN
• Primary DI: 00634916457643
• Version / Model: 74347089
• Catalog Number: 74347089
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2018-05-03
• Public Version: 2
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: bc96adec-0087-4544-84be-bc940e52d039
• Distribution End Date: 2019-09-13

Device Description

Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, single metal snap at front opening, OSFA

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
Primary	00634916457643	GS1
Unit of Use	10634916457643	GS1

Customer Contacts

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