FDA UDI In Commercial Distribution 🇺🇸 United States

RT300

DI: SA216652 · Model: RT300 clinic replacement (SLSA to SLSA) · RESTORATIVE THERAPIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
RT300
Primary DI
SA216652
Version / Model
RT300 clinic replacement (SLSA to SLSA)
Company Name
RESTORATIVE THERAPIES, INC.
Labeler DUNS
186976408
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
3
Public Version Date
2019-05-23
Public Version Status
Update
Public Device Record Key
d54015f8-d525-43c3-953a-de6ed0de81f4

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GZI Stimulator, Neuromuscular, External Functional

GMDN Terms

Code Name
46571 Physical therapy transcutaneous electrical stimulation system, line-powered

Identifiers

Type ID
Primary SA216652