NA

Primary DI
37613327282222
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
5140-522-603
Catalog number
5140-522-603
Device description
Bipolar Probe 45mm, angled 30¿
Published
2016-12-22
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

Product Codes

CodeName
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications

CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613327282222PackageGS110In Commercial Distribution
07613327282221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761332728222237613327282222
07613327282221076133272822217613327282221

GMDN Terms

TermDefinition
Nerve-locating system, line-poweredAn assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Device Sizes

TypeValueUnit
Angle30degree
Length45Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00TRANSPORT 10-90%, -20+50¿C
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
316153956
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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