FDA.report

Ear Tip PM016 Pack/100 pcs. (Grason)

Primary DI
04260223142147
Brand
Ear Tip PM016 Pack/100 pcs. (Grason)
Company
PATH medical GmbH
Model
100773-100
Device description
PATH MEDICAL is not manufacturer or Labeler of this product. The legal manufacturer confirmed to submit his UDI once stablished.
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications

CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260223142147PrimaryGS10
04260223142376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260223142147042602231421474260223142147
04260223142376042602231423764260223142376

GMDN Terms

TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Sterilization Methods

Method

Regulatory Flags

DUNS number
551540334
Device count
100
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
04260223147326nanoAudio DD45101414-012025-08-05
04260223147333nanoAudio DD65v2101414-022025-08-05
04260223147340nanoAudio Patient Response Button1014202025-08-05
04260223147418Sentiero Screening 3100098-S32025-08-05
04260223147449nanoAudio DD45 Set101470-012025-08-05
04260223147456nanoAudio DD45 Set with Patient Response Button101470-022025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake101470-032025-08-05
04260223147470nanoAudio DD65v2 Set101470-042025-08-05
04260223147487nanoAudio DD65v2 Set with Patient Response Button101470-052025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-Westlake101470-062025-08-05
04260223147630Sentiero Screening3 DPOAE Set100250-SC3-D-LT2025-08-05
04260223147647Sentiero Screening3 TEOAE Set100250-SC3-T-LT2025-08-05
04260223144783Headphone DD-65 v21010442024-09-17
04260223147272QScreen Set101275-AS-ECC2024-09-17
04260223147289QScreen Set101275-AS-EP2024-09-17
04260223147296QScreen Set101275-AS-IP2024-09-17
04260223147302QScreen Set101275-AS-HP2024-09-17
04260223142994Sentiero Desktop Diagnostic1004972024-05-22
04260223147210Ear Tip PM009H Pack/100 pcs.100767-PH-1002024-05-22
04260223147227Ear Tip PM010H Pack/100 pcs.100768-PH-1002024-05-22

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