FDA.report

NA

Primary DI
09008737080877
Brand
NA
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
Sterilization Tray
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MMOTray, Surgical, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09008737080877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09008737080877090087370808779008737080877

GMDN Terms

TermDefinition
Cochlear implant systemA battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)633-3524implants.us@medel.com

Regulatory Flags

DUNS number
300764032
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
09008737049997OPUS 2 FM Extension Kit anthracite049992022-09-15
09008737050009OPUS 2 Children's Extension Kit anthracite050002022-09-15
09008737050030OPUS 2 FM Extension Kit beige050032022-09-15
09008737050047OPUS 2 Children's Extension Kit beige050042022-09-15
09008737050078OPUS 2 FM Extension Kit red050072022-09-15
09008737050085OPUS 2 Children's Extension Kit red050082022-09-15
09008737050115OPUS 2 FM Extension Kit blue050112022-09-15
09008737050122OPUS 2 Children's Extension Kit blue050122022-09-15
09008737050153OPUS 2 FM Extension Kit grey050152022-09-15
09008737050160OPUS 2 Children's Extension Kit grey050162022-09-15
09008737050191OPUS 2 FM Extension Kit brown050192022-09-15
09008737050207OPUS 2 Children's Extension Kit brown050202022-09-15
09008737056414OPUS 2 Battery Pack Extension Kit anthracite056412022-09-16
09008737056421OPUS 2 Battery Pack Extension Kit beige056422022-09-16
09008737461379SONNET Battery Pack Cover Standard Pro, Anthracite461372026-02-26
09008737461386SONNET Battery Pack Cover Standard Pro, Ebony461382026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic Gray461392026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, Beige461402026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, White461412026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, Black461422026-02-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04250676747204Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747211Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747235Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747228Tray setSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993600128Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601927Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601934Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676741554Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741561Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741578Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741585Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741592Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741608Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741622Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741639Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741899Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250407778262FENTEXFENTEX medical GmbHMMO2025-02-19
00840217909396Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
00840217909402Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
40198459084776Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
00848253002347InHealth Technologies; Blom-SingerFreudenberg Medical, LLCMMO2023-11-03
00848253002354InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002361InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002378InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002385InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002408InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002606InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253003092InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253003115InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253003122InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03