FDA UDI In Commercial Distribution 🇺🇸 United States

MEDWIRE

DI: 08054301667303 · Model: MW20100-11 · MEDAX SRL UNIPERSONALE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
MEDWIRE
Primary DI
08054301667303
Version / Model
MW20100-11
Company Name
MEDAX SRL UNIPERSONALE
Labeler DUNS
440211428
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-10-29
Public Version
1
Public Version Date
2018-11-29
Public Version Status
New
Public Device Record Key
b2d7663d-8566-486a-80b6-5930afc7fef2

Device Description

REPOSITIONABLE BREAST LOCALIZATION NEEDLE FOR NON-PALPABLE LESIONS, 20G X 100 mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MIJ Needle, Tumor Localization

GMDN Terms

Code Name
47020 Imaging lesion localization marker, external, single-use

Identifiers

Type ID
Package 18054301667300
Primary 08054301667303