FDA.reportPublic FDA data

Bio Protech

Primary DI
00817120020715
Brand
Bio Protech
Company
BIO PROTECH USA, INC.
Model
DR-5
Device description
DR-5: Monopolar single use pencil, rocker switch; spatula electrode; L 5 m (1 pc per pack, 25 packs in a inner box, 50 packs in a master case)
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817120020712PackageGS125In Commercial Distribution
20817120020719PackageGS12In Commercial Distribution
00817120020715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002071210817120020712
2081712002071920817120020719
00817120020715008171200207158171200207150817120020715

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
909-464-1464bioprotechusa@gmail.com

Regulatory Flags#

DUNS number
789127011
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817120020609BLUE HAND03RD XTFA2026-07-07
00817120021460BLUE HAND1515SQ XTFO2026-07-07
00817120021477BLUE HAND1.5RD XTFO2026-07-07
00817120021484BLUE HAND02RD XTFO2026-07-07
00817120021491BLUE HAND22SQ XTFO2026-07-07
00817120021507BLUE HAND24RT XTFO2026-07-07
00817120021514BLUE HAND03RD XTFO2026-07-07
00817120020067BLUE HAND1515SQ XTFA2026-07-07
00817120020050Bio Protech48482026-05-07
00817120020043Bio Protech48482016-06-15
00817120020340Bio Protech4848WCBZGN(NST)2016-06-21
00817120021088Bio ProtechSG15R (Lifelines)2017-08-09
00817120021095Bio ProtechSG15G (Lifelines)2017-08-09
00817120021101Bio ProtechNCS-1334 (Lifelines)2017-08-09
00817120021118Bio ProtechNCS-SG15 (Lifelines)2017-08-09
00817120021125Bio ProtechMF2409 (Lifelines)2017-08-09
00817120020005Bio Protech MaxTens 1k 2016-06-15
00817120020074Bio ProtechMaxEMS 1k2016-06-16
00817120020081Bio Protech MaxEMS 2k2016-06-17
00817120020562Bio Protech MaxTens 1k Unit2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869062AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869154AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869185AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869185AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869215AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869215AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869277AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869277AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869307AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869338AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08718375861707Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08033315122299BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122312BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122336BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122350BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122374BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122398BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04