FDA UDI In Commercial Distribution 🇺🇸 United States

LIGHT SOURCE

DI: 04961333232802 · Model: LH-150PC · PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LIGHT SOURCE
Primary DI
04961333232802
Version / Model
LH-150PC
Company Name
PENTAX OF AMERICA, INC.
Labeler DUNS
083211284
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-04-06
Public Version
4
Public Version Date
2021-12-22
Public Version Status
Update
Public Device Record Key
e750085a-bc51-464b-9db6-59be50fe93db

Device Description

LH-150PC LIGHT SOURCE (REFURBISHED)

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
No
Has Serial Number
Yes
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
FCW Light Source, Fiberoptic, Routine

GMDN Terms

Code Name
35158 Endoscopic light source unit, line-powered

Identifiers

Type ID
Primary 04961333232802