Rultract

FDA UDI

Class I (US FDA UDI)

by Pemco, Inc.

Identity

Trade Name: RULTRACT FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: Riser Extender Bar w/ Cross Square 4" rise with 10-1/2" extension FDA UDI
Model / Reference: 4100-39R FDA UDI
Description: Riser Extender Bar w/ Cross Square 4" rise with 10-1/2" extension FDA UDI

Identifiers

Catalog Number: 4100-39R FDA UDI
Primary DI / UDI-DI: B152410039R0 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Surgical retraction system, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 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

Yes

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: Surgical retraction system, reusable

Rultract by Pemco, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical retraction system, reusable.

45930R — Thompson Surgical Instruments, Inc. · Class IIa
Sigma — ALPHATEC SPINE, INC. · Class I
Omni-Tract® — Integra Lifesciences Corp. · Class I
Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
Thompson — Thompson Surgical Instruments · Class I
Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
Thompson — Thompson Surgical Instruments · Class I
Thompson — Thompson Surgical Instruments · Class I

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: Pemco, Inc.

Sources (1)

FDA UDI c1005844-2cc0-4707-abbe-5c9be5fc3546 35 fields · synced May 30, 2026