FDA UDI In Commercial Distribution 🇺🇸 United States

Therapy US (FDA)

DI: 07898616351141 · Model: 980030035 · DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Therapy US (FDA)
Primary DI
07898616351141
Version / Model
980030035
Catalog Number
980030035
Company Name
DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
Labeler DUNS
904563269
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-17
Public Version
1
Public Version Date
2025-12-25
Public Version Status
New
Public Device Record Key
acb737d4-eae9-47f9-a245-b1056d6a1d8c

Device Description

Laser system for therapy

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

GMDN Terms

Code Name
60409 Musculoskeletal/physical therapy laser, professional

Identifiers

Type ID
Primary 07898616351141