FDA UDI In Commercial Distribution 🇺🇸 United States

NOVUS

DI: 08055715704196 · Model: NOVUS-4 TELAIO NERO, TAPPEZZERIA GRIGIO SCURO · ORMESA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
NOVUS
Primary DI
08055715704196
Version / Model
NOVUS-4 TELAIO NERO, TAPPEZZERIA GRIGIO SCURO
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
9326e201-9d69-4fb1-ab9e-632a935393de

Device Description

Postural reha-buggy intended for teens with important functional impairments, with little or no control of the head and trunk, with little or no functional capacity, who need a particularly robust structure for transport mainly outdoors.

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
INM Chair, With Casters

GMDN Terms

Code Name
31162 Assistive pushchair

Identifiers

Type ID
Primary 08055715704196