DEVICE: ERBE (04050147008038)

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Device Identifier (DI) Information

ERBE
20416-036
20416-036
Erbe Elektromedizin GmbH
04050147008038
GS1
1
Flexible cryo probe; for USA OD 1.9mm; L 900mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic cryosurgical probe A flexible distal component of a cryosurgical system intended to be inserted through the working channel of an endoscope for cryoadhesion and devitalization of tissues during bronchoscopy/interventional pulmonology. It is connected at the proximal end to the system control unit whereby gas expansion within the probe tip causes cooling of the tip based on the Joule-Thompson effect. It is typically intended for a variety of surgical applications (e.g., biopsy, recanalization, removal of blood clots). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GEH UNIT, CRYOSURGICAL, ACCESSORIES
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

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Size Type Text
Length: 900.000 Millimeter
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Device Status

In Commercial Distribution
September 09, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4970717550
info@erbe-med.com
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