Novoglan

Primary DI
00860009967205
Brand
Novoglan
Company
PLATIGO SOLUTIONS PTY LIMITED
Model
NFTE20221
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.
Published
2023-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009967205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009967205008600099672058600099672050860009967205

GMDN Terms#

Term, Definition table
TermDefinition
Penile foreskin stretching kitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
740341503
Device count
1
Premarket exempt
true
Kit
true