FDA UDI In Commercial Distribution 🇺🇸 United States

Dimension® Small Sample Container (SSC)

DI: 00842768005909 · Model: 10445040 · Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000

Basic Information

Brand Name
Dimension® Small Sample Container (SSC)
Primary DI
00842768005909
Version / Model
10445040
Catalog Number
DSC5
Company Name
Siemens Healthcare Diagnostics Inc.
Labeler DUNS
005088112
Distribution Status
In Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2020-09-24
Public Version
3
Public Version Date
2021-11-18
Public Version Status
Update
Public Device Record Key
bc6a8728-4f59-4d6d-ab04-e92fe3cacc04

Device Description

Small Sample Container (SSC) - Dimension® - 1000 Pieces

Device Characteristics

Single Use
Yes
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
No
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
JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

GMDN Terms

Code Name
62225 Assay container IVD, single-use

Identifiers

Type ID
Primary 00842768005909
Unit of Use 00630414004662

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K915106 000