FDA UDI In Commercial Distribution 🇺🇸 United States

BIOM 6 HD Optic Set for f=200 mm

DI: 04049584035721 · Model: 10029902 · OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
BIOM 6 HD Optic Set for f=200 mm
Primary DI
04049584035721
Version / Model
10029902
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
147c33c4-cd08-44d9-ad68-9a28e699019a

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HOH Spectacle, Operating (Loupe), Ophthalmic

GMDN Terms

Code Name
37184 Microscope objective

Identifiers

Type ID
Package 04049584035745
Primary 04049584035721