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Level One

FDA UDI

Class I (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
LEVEL ONE FDA UDI
Generic Name
Surgical water bath system FDA UDI
Device Name
CONTAINER, FOR XCELSIOR WATER BATH FDA UDI
Model / Reference
52-400-12-04 FDA UDI
Description
CONTAINER, FOR XCELSIOR WATER BATH FDA UDI

Identifiers

Primary DI / UDI-DI
00888118084781 FDA UDI
FDA Product Code
IRQ FDA UDI
GMDN Term
Surgical water bath system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5950 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical water bath system

Level One by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical water bath system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KLS-Martin L.P.

Sources (1)

  • FDA UDI bd7dd7e4-a370-4c67-91c9-95a38de67d88 34 fields · synced Jun 1, 2026