FDA UDI Not in Commercial Distribution 🇺🇸 United States

HALOGEN LIGHT SOURCE

DI: 04953170024511 · Model: OLYMPUS CLK-4 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HALOGEN LIGHT SOURCE
Primary DI
04953170024511
Version / Model
OLYMPUS CLK-4
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
9
Public Version Date
2024-01-15
Public Version Status
Update
Public Device Record Key
8bf5d423-0cf5-42cc-aa3a-bd31ac05bf1a
Distribution End Date
2024-01-12

Device Description

CLK-4 120V SIMPLIFIED LIGHT SOURCE

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FGA Kit, nephroscope
FAJ Cystoscope and accessories, flexible/rigid
KGE FORCEPS, BIOPSY, ELECTRIC
KNS Unit, electrosurgical, endoscopic (with or without accessories)

GMDN Terms

Code Name
35158 Endoscopic light source unit, line-powered

Identifiers

Type ID
Primary 04953170024511

Customer Contacts