Elite Medical Instrumentation

FDA UDI

Class I (US FDA UDI)

by Elite Medical Instrumentation

Identity

Trade Name: ELITE MEDICAL INSTRUMENTATION FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Walter Retractor, 19 cm, 4 Prongs FDA UDI
Model / Reference: EMI-S3BPS-015 FDA UDI
Description: Walter Retractor, 19 cm, 4 Prongs FDA UDI

Identifiers

Catalog Number: EMI-S3BPS-015 RETRACTOR FDA UDI
Primary DI / UDI-DI: G569EMIS3BPS0150 FDA UDI
FDA Product Code: EIG FDA UDI
GMDN Term: Self-retaining surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

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Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 19 Centimeter FDA UDI

Category: Self-retaining surgical retractor, reusable

Elite Medical Instrumentation by Elite Medical Instrumentation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-retaining surgical retractor, reusable.

Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
Life Instruments — Life Instrument Corporation · Class I
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: Elite Medical Instrumentation

Sources (1)

FDA UDI 87a50ce2-091f-447e-9b2a-e270023d946f 35 fields · synced May 31, 2026