KINCISE™ System Acetabular Cup Extraction Wrench

FDA UDI

Class I (US FDA UDI)

by Spierings Orthopaedics B.V.

Identity

Trade Name: KINCISE™ System Acetabular Cup Extraction Wrench FDA UDI
Generic Name: Surgical torque wrench, reusable FDA UDI
Model / Reference: KIN-2110-02 FDA UDI

Identifiers

Catalog Number: 200005017 FDA UDI
Primary DI / UDI-DI: 08720254007038 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Surgical torque wrench, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical torque wrench, reusable

KINCISE™ System Acetabular Cup Extraction Wrench by Spierings Orthopaedics B.V. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Spierings Orthopaedics B.V.

Sources (1)

FDA UDI da63f72c-4179-4d06-8015-7daa729e33a4 33 fields · synced May 31, 2026