FDA.reportPublic FDA data

Ambu

Primary DI
08718375869338
Brand
Ambu
Company
Technomed Engineering B.V.
Model
73605-190/1
Device description
Ambu ® Triple Hooked Probe 37x0.75mm 1pc
Published
2022-07-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
08718375869352PackageGS11Not in Commercial Distribution
08718375869338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718375869352087183758693528718375869352
08718375869338087183758693388718375869338

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system probe, single-useA hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+31434086868info@technomed.nl

Regulatory Flags#

DUNS number
418415568
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720791378172Technomed EuropeCS-SG01102026-07-08
08720791378189Technomed EuropeCS-SG02102026-07-08
08720791378196Technomed EuropeCS-SG03102026-07-08
08720791378202Technomed EuropeCS-SG01152026-07-08
08720791378219Technomed EuropeCS-SG02152026-07-08
08720791378226Technomed EuropeCS-SG03152026-07-08
08720791378233Technomed EuropeCS-SG01202026-07-08
08720791378240Technomed EuropeCS-SG02202026-07-08
08720791378257Technomed EuropeCS-SG03202026-07-08
08720791378264Technomed EuropeCS-SG01252026-07-08
08720791378271Technomed EuropeCS-SG02252026-07-08
08720791378288Technomed EuropeCS-SG03252026-07-08
08720791378295Technomed EuropeCS-ARR21102026-07-08
08720791378301Technomed EuropeCS-ARR23102026-07-08
08720791378318Technomed EuropeCS-ARR25102026-07-08
08720791378325Technomed EuropeCS-ARR27102026-07-08
08720791378332Technomed EuropeCS-ARR21152026-07-08
08720791378349Technomed EuropeCS-ARR23152026-07-08
08720791378356Technomed EuropeCS-ARR25152026-07-08
08720791378363Technomed EuropeCS-ARR27152026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869185AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869215AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869246AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869277AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869307AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375867129NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867143NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867167NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867181NatusTechnomed Engineering B.V.GXZ2021-04-01
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
08718375867556Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867570Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867884Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867891Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867327Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22
08718375867785Technomed EuropeTechnomed Engineering B.V.GXZ2020-07-22