AccessGUDID - DEVICE: SOLIDEA (08300496053613)

GUDID

Device Identifier (DI) Information

Brand Name: SOLIDEA
Version or Model: 053613
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0507A5
Company Name: CALZIFICIO PINELLI SRL

Primary DI Number: 08300496053613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431221795 *Terms of Use

Device Description: MICROMASSAGE ARMBANDS CCL1, SIZE M, FUCSIA, GRADUATED COMPRESSION 15/21 mmHg ARMBANDS

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64438	Compression/pressure tubular garment	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8af6f21a-685f-4d90-a2dd-d8a10894eb3f
Public Version Date: January 14, 2022
Public Version Number: 2
DI Record Publish Date: July 14, 2021