icotec Systems, Torque-Limiting Adapter, 3.5 Nm

FDA UDI

Class II (US FDA UDI)

by Icotec

Identity

Trade Name: icotec Systems, Torque-Limiting Adapter, 3.5 Nm FDA UDI
Generic Name: Surgical instrument torque limiter FDA UDI
Device Name: icotec Systems, Torque-Limiting Adapter, 3.5 Nm FDA UDI
Model / Reference: 60-035 FDA UDI
Description: icotec Systems, Torque-Limiting Adapter, 3.5 Nm FDA UDI

Identifiers

Catalog Number: 60-035 FDA UDI
Primary DI / UDI-DI: 07640172552872 FDA UDI
FDA Product Code: NKB FDA UDI
PML FDA UDI
GMDN Term: Surgical instrument torque limiter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical instrument torque limiter

icotec Systems, Torque-Limiting Adapter, 3.5 Nm by Icotec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Icotec

Sources (1)

FDA UDI 3695114c-4e6a-4342-8b72-1081d984612a 35 fields · synced Jun 8, 2026