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Otis-F

FDA UDI

Class I (US FDA UDI)

by S.b.m

Identity

Trade Name
OTIS-F FDA UDI
Generic Name
General surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Complete instrumentation tray composed of reusable OTIS-F surgical instruments. FDA UDI
Model / Reference
Complete OTIS-F tray FDA UDI
Description
Complete instrumentation tray composed of reusable OTIS-F surgical instruments. FDA UDI

Identifiers

Catalog Number
EVO9000000 FDA UDI
Primary DI / UDI-DI
03760154009492 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, reusable 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General surgical procedure kit, non-medicated, reusable

Otis-F by S.b.m — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
S.b.m

Sources (1)

  • FDA UDI c122d7ee-e9f6-4560-a2b2-67e6201b32b0 34 fields · synced May 30, 2026