FDA.reportPublic FDA data

Rochester

Primary DI
00849593025348
Brand
Rochester
Company
Advantage Medical Electronics, LLC
Model
NC-852637
Device description
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 26 GA, 37MM NEEDLE, GREEN
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593025348PackageGS125In Commercial Distribution
00849593025331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593025348008495930253488495930253480849593025348
00849593025331008495930253318495930253310849593025331

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080242300
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849593008355AMCRPO-LW-329DS50/5A2026-02-16
10849593008362AMCRPO-LW-329DS120/5A2026-02-16
10849593025857AMCRPO-LW-329DS50/3A2026-02-16
10849593025888AMCRPO-LW-329DS30/5AT2026-02-16
10849593025901AMCRPO-LW-329DS120/5AT2026-02-16
10849593025925AMCRPO-LW-341DS30/5A2026-02-16
10849593025956AMCRPO-LW-381DS50/3A2026-02-16
10849593025963AMCRPO-LW-381DS50/6A2026-02-16
10849593025864AMCRPO-LW-329DS30/5A2026-01-13
10849593025895AMCRPO-LW-329DS50/5AT2026-01-07
10849593025918AMCRPO-LW-341DS50/3A2026-01-07
10849593025932AMCRPO-LW-341DS50/5A2026-01-07
10849593025949AMCRPO-LW-341DS50/5V2026-01-07
10849593025710AMCLWM-314DS29/5AS2025-05-05
10849593025499AMCLW-314DS29/5AS2024-10-24
00849593025355RochesterNC-8523752023-02-08
00849593025379RochesterNC-8526502023-02-08
00849593025393RochesterNC-8527252023-02-08
00849593025416RochesterNC-8530252023-02-08
00849593017305AMCLW-329DS30/5A2020-06-10

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Primary DI, Brand, Company table
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08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
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08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.GXZ2021-06-02
08718375867129NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867143NatusTechnomed Engineering B.V.GXZ2021-04-01
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08718375867204NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867228NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867242NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867266NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867280NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867303NatusTechnomed Engineering B.V.GXZ2021-04-01
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08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22
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