FDA UDI In Commercial Distribution 🇺🇸 United States

Profile BreastBoardSX™ left

DI: 08720168161550 · Model: MBSX-BPL · MACROMEDICS B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Profile BreastBoardSX™ left
Primary DI
08720168161550
Version / Model
MBSX-BPL
Catalog Number
172420L
Company Name
MACROMEDICS B.V.
Labeler DUNS
489730120
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-21
Public Version
1
Public Version Date
2023-05-01
Public Version Status
New
Public Device Record Key
429506c9-38b3-478a-a7a4-9d5e9a14dcbb

Device Description

Carbon fiber profile breast mask for BreastBoard SX or OmniBoard Breast Treatment Module, left

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
MR Unsafe
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
IYE Accelerator, Linear, Medical

GMDN Terms

Code Name
40897 Indexed-immobilization patient positioning system

Identifiers

Type ID
Primary 08720168161550