Malis Retractor Set

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Malis Retractor Set FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Malis Retractor Set Consists of the Following: 1 x 7244-15 Malis Retractor Body Only, 1 x 7244-20 Malis Retractor Tower Attachment, 1 x 7244-25 Malis Retractor Swivel Clamp, 1 x 7244-30 Malis Retractor Arm Bar 9cm, 1 x 7244-35 Malis Retractor Arm Bar 12cm, 1 x 7244-40 Malis Retractor Arm Bar 15cm, 1 x 7244-45 Malis Retractor Blade 9x70mm, 1 x 7244-50 Malis Retractor Blade 14x70mm, 1 x 7244-55 Malis Retractor Blade 16x70mm, 1 x 7244-60 Malis Retractor Blade 19x70mm, 1 x 7244-65 Malis Retractor Blade 25x70mm, 1 x 7244-70 Malis Retractor Sterilizing Case FDA UDI
Model / Reference: 7244-10 FDA UDI
Description: Malis Retractor Set Consists of the Following: 1 x 7244-15 Malis Retractor Body Only, 1 x 7244-20 Malis Retractor Tower Attachment, 1 x 7244-25 Malis Retractor Swivel Clamp, 1 x 7244-30 Malis Retractor Arm Bar 9cm, 1 x 7244-35 Malis Retractor Arm Bar 12cm, 1 x 7244-40 Malis Retractor Arm Bar 15cm, 1 x 7244-45 Malis Retractor Blade 9x70mm, 1 x 7244-50 Malis Retractor Blade 14x70mm, 1 x 7244-55 Malis Retractor Blade 16x70mm, 1 x 7244-60 Malis Retractor Blade 19x70mm, 1 x 7244-65 Malis Retractor Blade 25x70mm, 1 x 7244-70 Malis Retractor Sterilizing Case FDA UDI

Identifiers

Catalog Number: 7244-10 FDA UDI
Primary DI / UDI-DI: 10840199508973 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Self-retaining surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

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: Self-retaining surgical retractor, reusable

Malis Retractor Set by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
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Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · 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: Koros USA, Inc.

Sources (1)

FDA UDI ee90088d-e1ae-4433-a584-2b8814312d44 37 fields · synced May 30, 2026