FDA.report

Ambu Concentric ProbeSingle Patient Probes

Primary DI
05707480108565
Brand
Ambu Concentric ProbeSingle Patient Probes
Company
Ambu A/S
Model
73603-190/10
Catalog number
73603-190/10
Device description
Ambu Disposable IOM Stimulation Probes 100 mm long Concentric with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXZELECTRODE, NEEDLE

Product Code Classifications

CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480108565PackageGS110In Commercial Distribution
05707480108688PackageGS134In Commercial Distribution
05707480108558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480108565057074801085655707480108565
05707480108688057074801086885707480108688
05707480108558057074801085585707480108558

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length100Millimeter
Length190Centimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
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

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