FDA UDI In Commercial Distribution 🇺🇸 United States

StemWear

DI: B1900691 · Model: PLB054-3050 · Tensproducts, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
StemWear
Primary DI
B1900691
Version / Model
PLB054-3050
Catalog Number
069
Company Name
Tensproducts, LLC
Labeler DUNS
104307787
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-15
Public Version
1
Public Version Date
2021-09-23
Public Version Status
New
Public Device Record Key
a4d764ae-350b-4a9d-8144-daa4ff645a01

Device Description

Conductive pan, 3in. x5in., 2/package

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
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
GXY Electrode, Cutaneous

GMDN Terms

Code Name
35995 Transcutaneous electrical stimulation electrode, single-use

Identifiers

Type ID
Primary B1900691