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Leos

FDA UDI

Class I (US FDA UDI)

by Tyber Medical

Identity

Trade Name
LEOS FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
LEOS Universal Caddy Lid FDA UDI
Model / Reference
7624-1104 FDA UDI
Description
LEOS Universal Caddy Lid FDA UDI

Identifiers

Catalog Number
7624-1104 FDA UDI
Primary DI / UDI-DI
00196449009992 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
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

Yes

FDA UDI

Category: Instrument tray, reusable

Leos by Tyber Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument tray, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyber Medical

Sources (1)

  • FDA UDI 9e64a97f-97b9-489f-937d-520c599b8296 35 fields · synced May 30, 2026