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Kalix®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name
KALIX® FDA UDI
Generic Name
Device sterilization/disinfection container, reusable FDA UDI
Device Name
The radel sterilization container is used in the transport and the sterilization of instruments, including one base with reference 119881ND and one lid with reference 119882ND. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
Model / Reference
119880ND FDA UDI
Description
The radel sterilization container is used in the transport and the sterilization of instruments, including one base with reference 119881ND and one lid with reference 119882ND. The transport and sterilization containers are not intended to maintain sterility. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780041689 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Device sterilization/disinfection container, 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

Yes

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

Kalix® by Newdeal Sas — 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
Newdeal Sas

Sources (1)

  • FDA UDI 9cc4664f-54c7-45a6-993f-0b3e6d600532 35 fields · synced May 30, 2026