Integra® Ruggles®-Redmond™

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: Integra® Ruggles®-Redmond™ FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: LOANER Ultra-Coat® and Diamond™ Detach Kerrison Rongeurs 11" Kit FDA UDI
Model / Reference: 0058LP FDA UDI
Description: LOANER Ultra-Coat® and Diamond™ Detach Kerrison Rongeurs 11" Kit FDA UDI

Identifiers

Catalog Number: 0058LP FDA UDI
Primary DI / UDI-DI: 10381780490203 FDA UDI
FDA Product Code: HAE FDA UDI
FSM FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4840 FDA UDI
878.4800 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable Spinal rongeur

Integra® Ruggles®-Redmond™ by Integra LifeSciences Production Corporation — 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: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI bcc1a64d-7222-442a-a51e-4633c52036ce 35 fields · synced Jun 9, 2026