Male Remeex System - Thread Passer

FDA UDI

Class II (US FDA UDI)

by Desarrollo E Investigacion Medica Aragonesa Sl

Identity

Trade Name: Male Remeex System - Thread Passer FDA UDI
Generic Name: Transvaginal mesh-sling introduction needle FDA UDI
Model / Reference: AR-07 FDA UDI

Identifiers

Primary DI / UDI-DI: 08436568350899 FDA UDI
FDA Product Code: OTM FDA UDI
GMDN Term: Transvaginal mesh-sling introduction needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3300 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Transvaginal mesh-sling introduction needle

Male Remeex System - Thread Passer by Desarrollo E Investigacion Medica Aragonesa Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Transvaginal mesh-sling introduction needle.

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Transvaginal 3.2 mm Introducer — CALDERA MEDICAL, INC. · Class II
Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class I
Desara Blue TVez 2.7 — CALDERA MEDICAL, INC. · Class II
Desara TVez 3.0 — CALDERA MEDICAL, INC. · Class II
Desara Blue TVez 3.0 — CALDERA MEDICAL, INC. · Class II
Desara Blue TVez 2.7 — CALDERA MEDICAL, INC. · Class II

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: Desarrollo E Investigacion Medica Aragonesa Sl

Sources (1)

FDA UDI 0998e3c3-3787-4a36-87d5-003fe156e3da 32 fields · synced May 30, 2026