FDA UDI In Commercial Distribution 🇺🇸 United States

Lumindex 3 LED Transilluminator Barrier Sleeves

DI: 00723896011164 · Model: 7118837 · PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Lumindex 3 LED Transilluminator Barrier Sleeves
Primary DI
00723896011164
Version / Model
7118837
Catalog Number
71-18837
Company Name
PRACTICON, INC.
Labeler DUNS
119193803
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2018-07-20
Public Version
1
Public Version Date
2018-08-20
Public Version Status
New
Public Device Record Key
1eb30472-50c3-452c-9b79-db209d981bb6

Device Description

cover light tip and Lumindex 3 handpiece to prevent cross-contamination.

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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIF Accessories, Retractor, Dental

GMDN Terms

Code Name
61049 Instrument/equipment drape, single-use, non-sterile

Identifiers

Type ID
Primary 00723896011164
Unit of Use 00723896009079