StimSite

Primary DI
00860002926919
Brand
StimSite
Company
Allotrope Medical Inc.
Model
AM 2101
Catalog number
AM 2101
Device description
Activation Card, StimSite, Single
Published
2022-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200886000StimSiteAllotrope Medical, Inc.2020-11-10ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002926919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002926919008600029269198600029269190860002926919

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating systemAn multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080572607
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002926902StimSiteAM 100AM 1002022-11-26
00860002926933StimSiteAM-DA1AM-DA12022-11-27
00860002926940StimSiteAM-LS1AM-LS12022-11-27
00860002926957StimSiteAM-BP1AM-BP12022-11-27

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