FDA UDI Not in Commercial Distribution 🇺🇸 United States

MRI Large Receive Coil

DI: 00850042098028 · Model: 6761-L · Promaxo, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MRI Large Receive Coil
Primary DI
00850042098028
Version / Model
6761-L
Catalog Number
6761-L
Company Name
Promaxo, Inc.
Labeler DUNS
103665187
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-27
Public Version
2
Public Version Date
2023-07-27
Public Version Status
Update
Public Device Record Key
954b9ea1-ba7c-4f88-8627-7fcad515bacf
Distribution End Date
2023-01-01

Device Description

The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

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
MOS Coil, Magnetic Resonance, Specialty

GMDN Terms

Code Name
40749 MRI system coil, radio-frequency

Identifiers

Type ID
Primary 00850042098028