FDA UDI In Commercial Distribution 🇺🇸 United States

K 180 LED OPHTHALMOSCOPE

DI: 04053755202232 · Model: 3,5 · Heine Optotechnik GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
K 180 LED OPHTHALMOSCOPE
Primary DI
04053755202232
Version / Model
3,5
Catalog Number
C-008.30.206
Company Name
Heine Optotechnik GmbH & Co. KG
Labeler DUNS
315274563
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-06-27
Public Version
1
Public Version Date
2024-07-05
Public Version Status
New
Public Device Record Key
ff5f5620-1c87-4914-8d27-c5355a960231

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
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
HLJ Ophthalmoscope, Battery-Powered

GMDN Terms

Code Name
46786 Direct ophthalmoscope

Identifiers

Type ID
Primary 04053755202232