FDA UDI In Commercial Distribution 🇺🇸 United States

SoftLab

DI: 00810055815616 · Model: 4.5.8.3 · SCC SOFT COMPUTER
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SoftLab
Primary DI
00810055815616
Version / Model
4.5.8.3
Company Name
SCC SOFT COMPUTER
Labeler DUNS
131311409
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-11
Public Version
1
Public Version Date
2023-02-20
Public Version Status
New
Public Device Record Key
fc40051c-22dd-4d2f-b533-cb75268e16e0

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JQP Calculator/Data Processing Module, For Clinical Use

GMDN Terms

Code Name
44082 Clinical laboratory information system application software

Identifiers

Type ID
Primary 00810055815616