FDA UDI In Commercial Distribution 🇺🇸 United States

PRISM COMPENSATOR for LENSMETER LM-8

DI: 04562123280531 · Model: PRISM COMPENSATOR for LENSMETER LM-8 · TOPCON CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PRISM COMPENSATOR for LENSMETER LM-8
Primary DI
04562123280531
Version / Model
PRISM COMPENSATOR for LENSMETER LM-8
Company Name
TOPCON CORPORATION
Labeler DUNS
690542881
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-31
Public Version
1
Public Version Date
2022-09-08
Public Version Status
New
Public Device Record Key
e47d325b-c121-4feb-a9e9-20de28525169

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
HLM Instrument, Measuring, Lens, Ac-Powered

GMDN Terms

Code Name
12326 Manually-adjusted lensmeter, line-powered

Identifiers

Type ID
Primary 04562123280531