FDA UDI In Commercial Distribution 🇺🇸 United States

3.6V PROFESSIONAL OPHTH IN CASE

DI: 05055272700788 · Model: 1128-P-1014 · KEELER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3.6V PROFESSIONAL OPHTH IN CASE
Primary DI
05055272700788
Version / Model
1128-P-1014
Company Name
KEELER LIMITED
Labeler DUNS
210164398
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-26
Public Version
5
Public Version Date
2023-12-05
Public Version Status
Update
Public Device Record Key
685ff4c2-905e-49a3-91a0-5b2f12231c4b

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HKL Retinoscope, Ac-Powered

GMDN Terms

Code Name
46786 Direct ophthalmoscope

Identifiers

Type ID
Primary 05055272700788