Alexis ® O C-Section Protector - Retractor

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: Alexis ® O C-Section Protector - Retractor FDA UDI
Generic Name: Radial surgical retractor FDA UDI
Device Name: Large, Disposable Alexis O C-Section Protector - Retractor FDA UDI
Model / Reference: G6313 FDA UDI
Description: Large, Disposable Alexis O C-Section Protector - Retractor FDA UDI

Identifiers

Primary DI / UDI-DI: 00607915118129 FDA UDI
FDA Product Code: KNA FDA UDI
KGW FDA UDI
GMDN Term: Radial surgical retractor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 FDA UDI
878.4370 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: Radial surgical retractor

Alexis ® O C-Section Protector - Retractor by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radial surgical retractor.

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CleanCision Wound Retraction and Protection System — Prescient Surgical, Inc. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class I
EZ Access™ — VLV ASSOCIATES, INC. · Class II
CleanCision™ Wound Retraction and Protection System — Prescient Surgical, Inc. · Class II
Medline — MEDLINE INDUSTRIES, 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 II	Pending data

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 0cb5d063-c322-4b7b-81e9-ee55a0d8ab12 35 fields · synced May 30, 2026