FDA UDI In Commercial Distribution 🇺🇸 United States

Twinfield 3

DI: 04049584037251 · Model: 10034819 · OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Twinfield 3
Primary DI
04049584037251
Version / Model
10034819
Company Name
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Labeler DUNS
317138956
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-14
Public Version
1
Public Version Date
2026-01-22
Public Version Status
New
Public Device Record Key
342b09d0-610b-4976-af87-28b44ee4da41

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
HPT Perimeter, Automatic, Ac-Powered
HOO Perimeter, Ac-Powered

GMDN Terms

Code Name
16918 Perimeter, automatic

Identifiers

Type ID
Primary 04049584037251