FDA.reportPublic FDA data

Neuromonitoring Kit

Primary DI
00863604000049
Brand
Neuromonitoring Kit
Company
Si-Bone Inc.
Model
400170
Device description
Neuromonitoring Kit
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161893000Neuromonitoring KitSI-BONE, Inc.2016-10-18PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863604000049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863604000049008636040000498636040000490863604000049

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating probe, single-useA sterile, hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG)], by delivering controlled electrical impulses to a specific body site for the measurement of a nerve 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-16 Degrees Celsius58 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-884-3873info@si-bone.com

Regulatory Flags#

DUNS number
830127168
Device count
1
Kit
true
Lot or batch
true

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00810055525232Onyx 5.5mm Navigated Cannulated Tap400539-05502026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated Tap400539-06502026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated Tap400539-07502026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip Tap400540-04502026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip Tap400540-05502026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip Tap400540-06502026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip Tap400540-07502026-09-30
00810055525720Onyx Navigated Locking Driver403035-01002026-09-30
00810055525966Onyx Navigated Locking Driver, Cannulated403035-02002026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mm503189-04502026-09-30
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008100555263905.5 mm x 25 mm iFuse Granite Onyx Implant055025BG2026-09-30
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008100555264135.5 mm x 35 mm iFuse Granite Onyx Implant055035BG2026-09-30
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