ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00019856058004
• Version / Model: 32-14-12A
• Catalog Number: 32-14-12A
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-29
• Public Version: 2
• Public Version Date: 2024-07-29
• Public Version Status: Update
• Public Device Record Key: 392ee22e-ff3d-498d-8aef-1a29d937e83d
• Distribution End Date: 2024-07-10

Device Description

WEISMAN PEDERSON VAGINAL SPECULUM, LEFT SIDE OPEN, 45 DEGREE HANDLE, MEDIUM - 4" X 7/8".

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35352	Vaginal speculum, reusable	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 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 at an angle. It is typically made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00019856058004	GS1

Customer Contacts

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