FDA.report

Bio Protech

Primary DI
30817120020501
Brand
Bio Protech
Company
BIO PROTECH USA, INC.
Model
3838WCBZ (NST)
Device description
3838WCBZ (NST) - 38x38mm Electrodes, White Fabric, Carbon, Plastic Zip Lock
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817120020507PackageGS110In Commercial Distribution
20817120020504PackageGS110In Commercial Distribution
30817120020501PackageGS15In Commercial Distribution
00817120020500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002050710817120020507
2081712002050420817120020504
3081712002050130817120020501
00817120020500008171200205008171200205000817120020500

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
714-730-9950bioprotechusa@gmail.com

Regulatory Flags

DUNS number
789127011
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817120021446Bio ProtechSaebo TENS Large Electrode (3pc/Pouch)2021-04-06
00817120021453Bio ProtechSaebo TENS Small Electrode (3pc/Pouch)2021-04-06
00817120021439Bio Protech4848TSBZ2020-07-09
30817120021423Bio ProtechElite- 75RdTSBA(NS) : 75mmRd Tricot Silver Film El2019-11-20
00817120020029Bio Protech MaxTens 1k 2016-06-15
00817120020036Bio Protech MaxTens 2k 2016-06-16
20817120020078Bio ProtechMaxEMS 1k2016-06-16
20817120020085Bio Protech MaxEMS 2k2016-06-17
20817120020566Bio Protech MaxTens 1k Unit2016-09-01
00817120020067Bio ProtechMaxIF 1k 2016-06-15
30817120020099Bio ProtechT715-502016-06-29
00817120020104Bio ProtechT716-32016-06-29
00817120020111Bio ProtechT716-302016-06-29
00817120020128Bio ProtechT716-52016-06-29
00817120020135Bio ProtechT716-502016-06-29
00817120020142Bio ProtechT716C-502016-06-29
00817120020159Bio ProtechT718-502016-06-29
00817120020166Bio ProtechT815-52016-06-29
00817120020173Bio ProtechT815-502016-06-29
00817120020180Bio Protech T816-302016-06-29

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