EARP Retractor

FDA UDI

Class I (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name: EARP Retractor FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: EARP Retractor, EARP BLADE 130. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area. FDA UDI
Model / Reference: EARP-R_001-130 FDA UDI
Description: EARP Retractor, EARP BLADE 130. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810135960724 FDA UDI
FDA Product Code: MDM 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

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

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

EARP Retractor by Nvision Biomedical Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-retaining surgical retractor, reusable.

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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: Nvision Biomedical Technologies, Inc

Sources (1)

FDA UDI 55bee357-c917-4c0d-b885-ab343ff9e0f2 34 fields · synced Jun 1, 2026