NA

Basic Information

• Brand Name: NA
• Primary DI: 04715309125076
• Version / Model: OS265BA-2
• Company Name: PANPAC MEDICAL CORPORATION
• Labeler DUNS: 657528899
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 3
• Public Version Date: 2020-06-25
• Public Version Status: Update
• Public Device Record Key: 4750adc5-55dc-4e73-84a0-48768924634f

Device Description

These Cervical Dilators are especially useful in locating and dilating the external OS, the cervical canal and the internal OS. They are particularly valuable instruments to be used on post-menopausal patients with cervical stenosis.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58389	Corpus cavernosum dilator, single-use	A sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of plastic; it is available in a set of graduated sizes that are applied in succession. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04715309122013	GS1	BOX	25	In Commercial Distribution
Primary	04715309125076	GS1

Customer Contacts

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