Small Component Box

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name: Small Component Box FDA UDI
Generic Name: Device sterilization/disinfection container, reusable FDA UDI
Device Name: To store small components during reprocessing FDA UDI
Model / Reference: GM11012300 FDA UDI
Description: To store small components during reprocessing FDA UDI

Identifiers

Primary DI / UDI-DI: 00816389028333 FDA UDI
510(k) Number: K160021 FDA UDI
FDA Product Code: JAQ FDA UDI
GMDN Term: Device sterilization/disinfection container, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5700 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Small Component Box by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160021 also covers:

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Varian Medical Systems, Inc

Sources (1)

FDA UDI 5b12043e-c997-4b6e-8314-50aefd678d94 35 fields · synced Jun 1, 2026