Device
BE YOU TONIC, SIZE L, FRAGOLA, GRADUATED COMPRESSION 15/21 mmHg OPAQUE MICRO-MASSAGING LEGGINGS WITH A THREE-DIMENSIONAL CONSTRUCTION FOR OUTDOOR USE
Manufacturer
CALZIFICIO PINELLI SRL
CALZIFICIO PINELLI SRL
Model: 073222
Catalog: 0602B5
DI: 08300496073222
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
BE YOU TONIC, SIZE L, FRAGOLA, GRADUATED COMPRESSION 15/21 mmHg OPAQUE MICRO-MASSAGING LEGGINGS WITH A THREE-DIMENSIONAL CONSTRUCTION FOR OUTDOOR USE
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d1644f69-9db4-45f8-96c8-a1d7707a3c59
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:
08300496073222
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
FQL
Stocking, Medical Support (For General Medical Purposes)