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Universal

FDA UDI

Class I (US FDA UDI)

by Orthosoft Inc

Identity

Trade Name
Universal FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Model / Reference
20-8000-020-19 FDA UDI

Identifiers

Catalog Number
20-8000-020-19 FDA UDI
Primary DI / UDI-DI
00889024304932 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
Not 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Universal by Orthosoft Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthosoft Inc

Sources (1)

  • FDA UDI ba9b94d0-19e7-45eb-b34c-5241713ce77b 35 fields · synced May 30, 2026