Leos

FDA UDI

Class I (US FDA UDI)

by Tyber Medical

Identity

Trade Name: LEOS FDA UDI
Generic Name: Orthopaedic implant reamer FDA UDI
Device Name: LEOS Ø22mm MTP Male Reamer FDA UDI
Model / Reference: 7624-3022 FDA UDI
Description: LEOS Ø22mm MTP Male Reamer FDA UDI

Identifiers

Catalog Number: 7624-3022 FDA UDI
Primary DI / UDI-DI: 00196449001811 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Orthopaedic implant reamer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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

Yes

FDA UDI

Category: Orthopaedic implant reamer

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

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Also classified as Orthopaedic implant reamer.

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DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
VADER Pedicle System, Trephine for Ø 5.5 mm Screw, Ø 5.5 mm — Icotec · Class II
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DJO SURGICAL — ENCORE MEDICAL, L.P. · 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: Tyber Medical

Sources (1)

FDA UDI 65c39d56-9176-49b5-a222-e735321d38d0 35 fields · synced Jun 8, 2026