FDA UDI In Commercial Distribution 🇺🇸 United States

GEM-STIM

DI: 04712832960280 · Model: Arista 2000 · GEMORE TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
GEM-STIM
Primary DI
04712832960280
Version / Model
Arista 2000
Catalog Number
Arista 2000
Company Name
GEMORE TECHNOLOGY CO., LTD.
Labeler DUNS
658435078
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
8
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
fa82d1aa-fa61-4dc6-b5bd-27b1927ac46f

Device Description

GM3A10T(0) Analog TENS

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
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 04712832960280
Package 24712832960284