Device
SKIN, SIZE S, BLU TONIC, MICRO-MASSAGING BRA WITH A THREE-DIMENSIONAL CONSTRUCTION FOR A COMFORTABLE BREAST SUPPORT
Manufacturer
CALZIFICIO PINELLI SRL
Model: 073314 Catalog: 0613A5 DI: 08300496073314 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-05-15 Current Version: 2026-05-25
Description
SKIN, SIZE S, BLU TONIC, MICRO-MASSAGING BRA WITH A THREE-DIMENSIONAL CONSTRUCTION FOR A COMFORTABLE BREAST SUPPORT
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: fc5dd655-0abd-4c4e-8e39-f8096010e57a
Distribution Status: In Commercial Distribution
DUNS Number: 431221795
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08300496073314
Type: Primary
Issuing Agency: GS1
GMDN
Code: 64438
Name: Compression/pressure tubular garment
Definition:
A device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.
FDA Product Codes
MDR
Binder, Medical, Therapeutic