FDA UDI In Commercial Distribution 🇺🇸 United States

VENTANA DP 600 slide scanner

DI: 07613336206737 · Model: 09311360001 · Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
VENTANA DP 600 slide scanner
Primary DI
07613336206737
Version / Model
09311360001
Catalog Number
09311360001
Company Name
Roche Diagnostics GmbH
Labeler DUNS
315028860
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-15
Public Version
1
Public Version Date
2025-12-23
Public Version Status
New
Public Device Record Key
9cd41077-7089-4315-8e20-45407a171e21

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
No
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
PSY Whole slide imaging system

GMDN Terms

Code Name
62575 Microscope slide digital imaging scanner IVD

Identifiers

Type ID
Primary 07613336206737