Novoglan

Basic Information

• Brand Name: Novoglan
• Primary DI: 00860009967205
• Version / Model: NFTE20221
• Company Name: PLATIGO SOLUTIONS PTY LIMITED
• Labeler DUNS: 740341503
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-16
• Public Version: 1
• Public Version Date: 2023-05-24
• Public Version Status: New
• Public Device Record Key: ac2e0848-d623-406f-a16f-25175f3c36ae

Device Description

A collection of devices intended to be operated by a patient at home to stretch the foreskin of the penis to treat phimosis (tightening of the foreskin) or to preferentially develop a looser foreskin. It consists of a balloon assembly, an inflator, cotton buds, insertion rods, and cleansing swabs. The inflatable balloon is inserted through the natural opening of the foreskin and positioned between the glans penis and the foreskin and inflated. This procedure is typically performed daily for a period (e.g., 14 days) to gradually stretch the foreskin. This is a single-patient device reapplied to the patient over a short term (single-use) before being discarded.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52752	Penile foreskin stretching kit	A collection of devices intended to be operated by a patient at home to stretch the foreskin of the penis to treat phimosis (tightening of the foreskin) or to preferentially develop a looser foreskin. It typically consists of a balloon assembly, an inflator, cotton buds, insertion rods, and cleansing swabs. The inflatable balloon is inserted through the natural opening of the foreskin and positioned between the glans penis and the foreskin and inflated. This procedure is typically performed daily for a period (e.g., 14 days) to gradually stretch the foreskin. This is a single-patient device reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009967205	GS1