Peritron

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name: Peritron FDA UDI
Generic Name: Perineometer FDA UDI
Device Name: with Anal Sensor FDA UDI
Model / Reference: PRN09300 FDA UDI
Description: with Anal Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 10627825006276 FDA UDI
510(k) Number: K983052 FDA UDI
FDA Product Code: HIR FDA UDI
GMDN Term: Perineometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Perineometer

A comprehensive medical device directory entry for the Peritron, a reliable and accurate Perineometer (Urinary Incontinence Device) designed to diagnose and treat urinary incontinence and sexual dysfunction through voluntary muscle contractions.

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Cleared under the same submission

K983052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Laborie Medical Technologies Canada ULC

Sources (1)

FDA UDI 50a928b1-5412-478f-ac27-4e00fe845623 34 fields · synced Jul 21, 2026