HT

Basic Information

• Brand Name: HT
• Primary DI: 06972952009018
• Version / Model: 42”*30”
• Company Name: Changzhou Hongtai Paper Film Co.,Ltd.
• Labeler DUNS: 546797065
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-31
• Public Version: 1
• Public Version Date: 2023-11-08
• Public Version Status: New
• Public Device Record Key: afb5dd0c-7ea5-4684-b7bd-5bf6c37bcd2c

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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
35092	Patient gown, single-use	A non-sterile garment made of natural and/or synthetic materials (e.g., paper, 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 may be closed by ties at the back/side of the garment. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972952009018	GS1