FDA.reportPublic FDA data

Invotec Single Channel Electrode

Primary DI
10818501020024
Brand
Invotec Single Channel Electrode
Company
INVOTEC INTERNATIONAL, INC.
Model
1
Catalog number
29-80500S
Device description
Invotec Single Channel Electrode, Standard The Laryngeal Surface Electrode is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.
Published
2017-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
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
K122040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122040000INVOTEC LARYNGEAL ELECTRODEInvotec International, Inc.2013-10-31ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818501020024PackageGS15In Commercial Distribution
00818501020027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081850102002410818501020024
00818501020027008185010200278185010200270818501020027

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic endotracheal tube electrodeA sterile electrical-conducting strip intended to be attached to an endotracheal tube to conduct the electromyographic (EMG) activity of the laryngeal and vocal cord musculature while the tube is in situ. It is used to assess the status of the nerves supplying the laryngeal musculature during surgery. It is intended to be connected to an appropriate EMG measuring/recording device, and may be supplied with a ground electrode. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622812592
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818501023158Invotec Forceps 129-808002023-07-18
00818501021161Invotec Silicone Sheeting20-2068020-206802022-12-07
00818501021178Invotec Silicone Sheeting20-2068220-206822022-12-07
00818501021185Invotec Silicone Sheeting20-2068520-206852022-12-07
00818501021956Invotec PVA Nasal Dressing22-6040022-604002022-12-07
00818501021963Invotec PVA Nasal Dressing22-60400P22-60400P2022-12-07
00818501021970Invotec PVA Nasal Dressing22-6040222-604022022-12-07
00818501021987Invotec PVA Nasal Dressing22-60402P22-60402P2022-12-07
00818501021994Invotec PVA Nasal Dressing22-6040622-604062022-12-07
00818501022007Invotec PVA Nasal Dressing22-60406P22-60406P2022-12-07
00818501022014Invotec PVA Nasal Dressing22-6040922-604092022-12-07
00818501022021Invotec PVA Nasal Dressing22-60409P22-60409P2022-12-07
00818501022038Invotec PVA Nasal Dressing22-6041022-604102022-12-07
00818501022045Invotec PVA Nasal Dressing22-60410P22-60410P2022-12-07
00818501022052Invotec PVA Nasal Dressing22-6041122-604112022-12-07
00818501022069Invotec PVA Nasal Dressing22-60411P22-60411P2022-12-07
00818501022076Invotec PVA Nasal Dressing22-6041322-604132022-12-07
00818501022083Invotec PVA Nasal Dressing22-60413P22-60413P2022-12-07
00818501022090Invotec PVA Nasal Dressing22-6041422-604142022-12-07
00818501022106Invotec PVA Nasal Dressing22-6042122-604212022-12-07

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