Sterling Medical Products

Basic Information

• Brand Name: Sterling Medical Products
• Primary DI: 00685404001404
• Version / Model: 944705
• Company Name: APOLLO MEDICAL PRODUCTS CORP.
• Labeler DUNS: 116768422
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-09
• Public Version: 1
• Public Version Date: 2019-10-17
• Public Version Status: New
• Public Device Record Key: 40f2ccf8-3e35-4918-ac05-c5b9da9f310f

Device Description

Sonohysterography and Hysterosalpongography Catheters

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
42912	Hysterosonography/endometrial biopsy catheter	A flexible tube designed for combined saline infusion sonohysterography (SIS) and biopsy functionality providing the physician with increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to take a biopsy of endometrial tissue during the same gynaecological procedure. It is introduced via the vagina and allows the uterus to be filled with saline which is retained with an acorn-tipped stopper placed against the cervical opening; a biopsy can be taken if indicated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10685404001401	GS1	carton	10	In Commercial Distribution
Primary	00685404001404	GS1

Customer Contacts

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