FDA.reportPublic FDA data

NA

Primary DI
37613327292207
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
5140-530-855
Catalog number
5140-530-855
Device description
Laryngeal Electrode Select, ID 6-7mm
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

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327292207PackageGS110In Commercial Distribution
07613327292206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332729220737613327292207
07613327292206076133272922067613327292206

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327682717NA92-0232592-023252026-02-27
07613327682724NA92-0232492-023242026-02-27
37613327090810NA92-1710592-171052015-09-24
37613327090827NA92-1710492-171042015-09-24
37613327090834NA92-1710692-171062015-09-24
37613327090841NA92-1710892-171082015-09-24
37613327090858NA92-8170392-817032015-09-24
37613327090865NA92-8170492-817042015-09-24
37613327090872NA92-8170592-817052015-09-24
37613327090889NA92-8170692-817062015-09-24
37613327090902NA92-8170892-817082015-09-24
37613327090919NA92-8171092-817102015-09-24
37613327090926NA92-8171292-817122015-09-24
37613327090940NA92-8190592-819052015-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327680522NA92-5553192-555312025-07-31
07613327651461NA92-0551292-055122025-07-09
07613327504385NA92-0233392-023332020-05-12
07613327504392NA92-0233292-023322020-05-12
07613327353563NA6002-140-2006002-140-2002025-02-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150023868N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00199150023875N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00199150023882N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00840067103029ZenithCADWELL INDUSTRIES, INC.ETN2025-12-31
00810155862664NONE Neurovision Medical Products, Inc.ETN2025-12-19
00810155862688NONENeurovision Medical Products, Inc.ETN2025-12-19
08720791377717InomedTechnomed Engineering B.V.ETN2025-12-10
08720791377724InomedTechnomed Engineering B.V.ETN2025-12-10
08720791377731InomedTechnomed Engineering B.V.ETN2025-12-10
00643169547087NIM®MEDTRONIC XOMED, INC.ETN2025-09-13
00763000831479NIM™MEDTRONIC XOMED, INC.ETN2025-08-11
20763000831480NIM™MEDTRONIC XOMED, INC.ETN2025-08-11
20763000831497NIM™MEDTRONIC XOMED, INC.ETN2025-08-11
14250307612076N/Ainomed Medizintechnik GmbHETN2025-05-02
14250307612083N/Ainomed Medizintechnik GmbHETN2025-05-02
00816312027570Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCETN2025-03-21
B066HGELS1NONENEUROVISION MEDICAL PRODUCTS, INC.ETN2025-02-12
B006IJCBFB60NONENEUROVISION MEDICAL PRODUCTS, INC.ETN2025-02-12
00763000835330NIM NeuroMEDTRONIC XOMED, INC.ETN2025-01-23
00190376530024SafeOp 3ALPHATEC SPINE, INC.ETN2024-11-12
00763000842543Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
00763000842550Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
00763000842567Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
00763000891862ENT NIM ElectrodeMEDTRONIC XOMED, INC.ETN2024-09-23
00763000891879ENT NIM ElectrodeMEDTRONIC XOMED, INC.ETN2024-09-23
00763000580483ENT NIM VitalMEDTRONIC XOMED, INC.ETN2024-09-19
00763000576769N/AMEDTRONIC XOMED, INC.ETN2024-09-14
00763000576776N/AMEDTRONIC XOMED, INC.ETN2024-09-14