Gongdong

Basic Information

• Brand Name: Gongdong
• Primary DI: 06947462400419
• Version / Model: 2102
• Company Name: ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
• Labeler DUNS: 529309049
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-28
• Public Version: 1
• Public Version Date: 2023-04-05
• Public Version Status: New
• Public Device Record Key: 091d76bb-18f5-40c0-bf02-0b854f27e2e8

Device Description

3. Device description: (for example) Disposable vaginal speculum, large.DISPOSABLE VAGINAL SPECULUM, MEDIUM

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37468	Vaginal speculum, single-use	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16947462400416	GS1	carton	20	In Commercial Distribution
Primary	06947462400419	GS1