FDA UDI In Commercial Distribution 🇺🇸 United States

Thermo Fisher

DI: 05051663008617 · Model: REVOS · SHANDON DIAGNOSTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Thermo Fisher
Primary DI
05051663008617
Version / Model
REVOS
Company Name
SHANDON DIAGNOSTICS LIMITED
Labeler DUNS
219103512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-16
Public Version
3
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
d5f415f8-3f77-49f7-9a45-2fa2d3382e3a

Device Description

100-240V 50/60HZ

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IEO Processor, Tissue, Automated

GMDN Terms

Code Name
57859 Tissue processor IVD, automated/semi-automated

Identifiers

Type ID
Primary 05051663008617