FDA UDI In Commercial Distribution 🇺🇸 United States

June Medical Galaxy II LUX Connect Surgical Illuminator

DI: 00812432022471 · Model: 012569 · LUMITEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
June Medical Galaxy II LUX Connect Surgical Illuminator
Primary DI
00812432022471
Version / Model
012569
Catalog Number
JUNELuxC1
Company Name
LUMITEX, INC.
Labeler DUNS
108631797
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-23
Public Version
2
Public Version Date
2021-12-22
Public Version Status
Update
Public Device Record Key
40602910-94cc-48e1-8708-2f3917ca7edd

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FDG Retractor, Fiberoptic

GMDN Terms

Code Name
65349 Open surgical site internal light

Identifiers

Type ID
Primary 00812432022471