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SOAR Retractor System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
SOAR Retractor System FDA UDI
Generic Name
Hand-held surgical retractor, single-use FDA UDI
Device Name
22mm x 120mm Portal Tube FDA UDI
Model / Reference
78-02-02-8 FDA UDI
Description
22mm x 120mm Portal Tube FDA UDI

Identifiers

Catalog Number
304-2212 FDA UDI
Primary DI / UDI-DI
M7403042212 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Hand-held surgical retractor, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 22 Millimeter FDA UDI
Length — 120 Millimeter FDA UDI

Category: Hand-held surgical retractor, single-use

SOAR Retractor System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held surgical retractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 1c8383ca-514d-436e-8886-e956883e6374 36 fields · synced Jun 8, 2026