FDA UDI In Commercial Distribution 🇺🇸 United States

DYNAMICO

DI: 08055715700815 · Model: DYNAMICO-2 · ORMESA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DYNAMICO
Primary DI
08055715700815
Version / Model
DYNAMICO-2
Company Name
ORMESA SRL
Labeler DUNS
432070019
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-31
Public Version
1
Public Version Date
2025-02-10
Public Version Status
New
Public Device Record Key
ea0897c6-d539-4af9-8f6b-8f66e86f382d

Device Description

Walking frame intended to provide support and safety to those subjects with reduced functional capacity of maintaining the upright position and walking independently; subjects with disabilities and impaired functional residual capacity or even semi-self-sufficient elderly subjects who must be protected during walking.

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ITJ Walker, Mechanical

GMDN Terms

Code Name
31119 Handgrip disability-assistive walker, non-powered, non-foldable

Identifiers

Type ID
Primary 08055715700815