FDA UDI Not in Commercial Distribution 🇺🇸 United States

Getinge 600 Series

DI: 05902533503155 · Model: 633HC · GETINGE IC PRODUCTION POLAND SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Getinge 600 Series
Primary DI
05902533503155
Version / Model
633HC
Catalog Number
6BSVUPHTA4AA
Company Name
GETINGE IC PRODUCTION POLAND SP Z O O
Labeler DUNS
427370513
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2021-05-10
Public Version Status
Update
Public Device Record Key
6fd6f10a-5423-4d18-9e8e-32462d989eec
Distribution End Date
2020-01-01

Device Description

Steam Sterilizer - 633HC,L2,SD,DU,TRK,PWR,460BD

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FLE Sterilizer, Steam

GMDN Terms

Code Name
38671 Steam sterilizer

Identifiers

Type ID
Primary 05902533503155

Premarket Submissions

Submission Number Supplement Number
K070657 000