FDA UDI In Commercial Distribution 🇺🇸 United States

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DI: 00850921007233 · Model: ER 12.0 MHz · INTERSON CORP
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
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Primary DI
00850921007233
Version / Model
ER 12.0 MHz
Catalog Number
99-5942
Company Name
INTERSON CORP
Labeler DUNS
079884004
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-02
Public Version
2
Public Version Date
2018-05-23
Public Version Status
Update
Public Device Record Key
91eac153-706f-4c3d-a844-d8a0deee7668

Device Description

USB ultrasound probe

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
ITX Transducer, Ultrasonic, Diagnostic
IYO System, Imaging, Pulsed Echo, Ultrasonic

GMDN Terms

Code Name
40768 Extracorporeal ultrasound imaging transducer, hand-held

Identifiers

Type ID
Primary 00850921007233

Customer Contacts

Phone
925-462-4948