Insertion Probe

GUDID 09008737335632

Single-Use Surgical Tool

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Abdominal/ENT/orthopaedic surgical probe, single-use
Primary Device ID09008737335632
NIH Device Record Keyc644ebf7-2766-4a47-8739-82ad3b7ac1e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsertion Probe
Version Model Number33563
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the sterilized contents in this box at room temperature until the stated expiry date.

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737335632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-01
Device Publish Date2024-10-24

Devices Manufactured by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

09008737335632 - Insertion Probe2024-11-01Single-Use Surgical Tool
09008737335632 - Insertion Probe2024-11-01 Single-Use Surgical Tool
09008737369736 - ANTS Connector Cable2024-11-01 Cable
09008737370053 - Stimulator Box2024-11-01 Hardware Interface System
09008737371371 - ANTS Electrode2024-11-01 Diagnostic Electrode
09008737405557 - Insertion Probe L2024-11-01 Single-Use Surgical Tool
09008737415433 - Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet2024-10-23 Cochlear Implant
09008737415440 - Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet2024-10-23 Cochlear Implant
09008737416218 - Insertion Electrode FLEX342024-10-23 Insertion Electrode
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