FDA.reportPublic FDA data

SentioMMG

Primary DI
00853926005013
Brand
SentioMMG
Company
INNOVATIVE SURGICAL SOLUTIONS LLC
Model
2012
Catalog number
2012
Device description
Stimulation Sterile Disposables
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K131304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131304000SENTIO MMGInnovative Surgical Solutions, LLC ("Iss")2014-05-29PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853926005013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853926005013008539260050138539260050130853926005013

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013197873
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853926005020SentioMMG200720072016-09-24
00853926005037SentioMMG200820082016-09-24
00853926005044SentioMMG200920092016-09-24
00853926005006SentioMMG200620062016-09-24
00853926005051SentioMMG201020102016-09-24
00853926005068SentioMMG201124A052016-09-24

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