FDA UDI Not in Commercial Distribution 🇺🇸 United States

18L5S SMALL ARRAY LINEAR TRANSDUCER

DI: 60889971734617 · Model: 18L5S SMALL ARRAY LINEAR TRANSDUCER · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
18L5S SMALL ARRAY LINEAR TRANSDUCER
Primary DI
60889971734617
Version / Model
18L5S SMALL ARRAY LINEAR TRANSDUCER
Catalog Number
1734615
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
6
Public Version Date
2020-09-18
Public Version Status
Update
Public Device Record Key
65c23927-3ee2-44ac-99d3-4640e4f78915
Distribution End Date
2020-06-08

Device Description

18L5S SMALL ARRAY LINEAR TRANSDUCER

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
Yes
Sterilization Methods
Hydrogen Peroxide

Product Codes

Code Name
ITX Transducer, ultrasonic, diagnostic

GMDN Terms

Code Name
40761 General-purpose ultrasound imaging system

Identifiers

Type ID
Primary 60889971734617