Device
STEAM STERILIZER HC - 533HC-E,L1,DD,460 VPS SST,DU,PWR,TRK,REC
Manufacturer
GETINGE IC PRODUCTION POLAND SP Z O O
GETINGE IC PRODUCTION POLAND SP Z O O
Model: 533HC
Catalog: 5SDUUPHTAAAA
DI: 05902533549511
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-15
Current Version: 2026-05-25
Description
STEAM STERILIZER HC - 533HC-E,L1,DD,460 VPS SST,DU,PWR,TRK,REC
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a2ec0d8f-2c99-4d76-8459-ce81da32f29c
Distribution Status:
In Commercial Distribution
DUNS Number:
427370513
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05902533549511
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38671
Name: Steam sterilizer
Definition:
A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.
FDA Product Codes
FLE
Sterilizer, Steam
Premarket Submissions
Submission Number:
K122071
Supplement Number:
000