FDA.report

Ambu®

Primary DI
08720791371005
Brand
Ambu®
Company
Technomed Engineering B.V.
Model
73600-190/10
Device description
Ambu® Pedicle Screw Probe, 3mm ball 100x0.75mm 10pcs
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
08720791371005PackageGS110In Commercial Distribution
08720791371012PackageGS110In Commercial Distribution
08720791370992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08720791371005087207913710058720791371005
08720791371012087207913710128720791371012
08720791370992087207913709928720791370992

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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

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08720791378592Technomed EuropeTE/C53-4382025-11-11
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08720791378615Technomed EuropeTE/C53-8382025-11-11
08720791378622Technomed EuropeTE/C53-9382025-11-11
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