FDA.report

SME

Primary DI
10851004007086
Brand
SME
Company
SME, INC. USA
Model
F206
Catalog number
F206
Device description
Supertrode 2.75" Round Foam
Published
2017-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851004007086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1085100400708610851004007086

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter2.75Inch

Sterilization Methods

Method

Contacts

PhoneEmail
910-798-0500ordernow@smeincusa.com

Regulatory Flags

DUNS number
008264868
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10851004007093SMEF210F2102017-03-01
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00851004007140SMESMEGSMEG2018-05-30
00851004007157SMESMELSMEL2016-10-31
00851004007126SMESMEGSMEG2016-10-31

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