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Skytron

FDA UDI

Class I (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
Skytron FDA UDI
Generic Name
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
3 Inch Sof Pad F/ 12 Inch Carbon Fiber Armboard FDA UDI
Model / Reference
2-010-05-3S FDA UDI
Description
3 Inch Sof Pad F/ 12 Inch Carbon Fiber Armboard FDA UDI

Identifiers

Catalog Number
2-010-05-3S FDA UDI
Primary DI / UDI-DI
10841736121846 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Operating table patient pressure distribution pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table patient pressure distribution pad, reusable

Skytron by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skytron, LLC

Sources (1)

  • FDA UDI 2c6ea8c2-76e9-4eca-844b-0a1ffa9357a4 36 fields · synced Jun 7, 2026