FDA.report

Probe Cable Clip

Primary DI
05060396170386
Brand
Probe Cable Clip
Company
OTODYNAMICS LIMITED
Model
PR-CLIP
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications

CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060396170386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060396170386050603961703865060396170386

GMDN Terms

TermDefinition
Otoacoustic emission system, line-poweredAn assembly of mains electricity (AC-powered) devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods

Method

Regulatory Flags

DUNS number
235908050
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
05060396171130Crib/bassinet device holster for OtoNovaNOVA-CRIB2024-08-20
05060396171512Tablet Computer for OtoNova Pro NOVA-TABLET2024-08-20
05060396171529OtoNova ChargerNOVA-CHG2024-08-20
05060396171536OtoNova Wireless Charging PadNOVA-CHG-PAD2024-08-20
05060396172243XPD Ear ProbePR-XPD2024-08-20
05060396172359ABR Electrode Cable (SNAP) for OtoNova ProNPRO-SEC2024-08-20
05060396172366ABR Electrode Cable (TAB) for OtoNova ProNPRO-TEC2024-08-20
05060396172809OtoNova Battery Assembly Service KitON-BATT-KIT2024-08-20
05060396173011OtoNova Pro OAE+AABR instrumentOTONOVAPRO2024-08-20
05060396173042OtoNova Pro Main PCB Service KitON2-MAIN2024-08-20
05060396173059OtoNova Pro Charger PCB Service KitON2-CHG-KIT2024-08-20
05060396173080OtoNova Pro Case Service KitON2-CASE-KIT2024-08-20
05060396173103OtoNova Pro Screener TENPRO-SCR-T2024-08-20
05060396173110OtoNova Pro Screener DPNPRO-SCR-D2024-08-20
05060396173127OtoNova Pro Screener AABRNPRO-SCR-A2024-08-20
05060396173134OtoNova Pro Screener DP+TENPRO-SCR-DT2024-08-20
05060396173141OtoNova Pro Screener TE+AABRNPRO-SCR-TA2024-08-20
05060396173158OtoNova Pro Screener DP+AABRNPRO-SCR-DA2024-08-20
05060396173165OtoNova Pro Screener DP+TE+AABRNPRO-SCR-DTA2024-08-20
05060396173172OtoNova Pro Clinical+TE+AABRNPRO-CLN-DTA2024-08-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05713315012068Echo-Screen IIINatus Medical Denmark ApSGWJ2026-01-29
05713315012013Echo-Screen IIINatus Medical Denmark ApSGWJ2026-01-28
05713315012037Echo-Screen IIINatus Medical Denmark ApSGWJ2026-01-28
05713315012051Echo-Screen IIINatus Medical Denmark ApSGWJ2026-01-28
05713315011436ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011443ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011450ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011467ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011474ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011481Algo ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011498ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011504ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011511ALGO ProNatus Medical Denmark ApSGWJ2026-01-23
05713315011726Algo 3iNatus Medical Denmark ApSGWJ2025-12-17
05713315012211Algo 3iNatus Medical Denmark ApSGWJ2025-12-17
05713315012228Algo 3iNatus Medical Denmark ApSGWJ2025-12-17
05713315012235Algo 3iNatus Medical Denmark ApSGWJ2025-12-17
05713315012242Algo 3iNatus Medical Denmark ApSGWJ2025-12-17
05713315011702FlexicouplerNatus Medical Denmark ApSGWJ2025-12-11
05713315011979 ALGONatus Medical Denmark ApSGWJ2025-12-11
05713315011986FlexicouplerNatus Medical Denmark ApSGWJ2025-12-11
05713315011993FlexicouplerNatus Medical Denmark ApSGWJ2025-12-11
05713315011733Jelly Tab SensorsNatus Medical Denmark ApSGWJ2025-12-02
05713315011740Jelly Tab SensorsNatus Medical Denmark ApSGWJ2025-12-02
05713315012006Jelly Tab SensorsNatus Medical Denmark ApSGWJ2025-12-02
05713315012167ALGO 5Natus Medical Denmark ApSGWJ2025-12-02
05713315012174ALGO 5Natus Medical Denmark ApSGWJ2025-12-02
05713315012181ALGO 5Natus Medical Denmark ApSGWJ2025-12-02
05713315012198ALGO 5Natus Medical Denmark ApSGWJ2025-12-02
05713315012204ALGO 5Natus Medical Denmark ApSGWJ2025-12-02