DEVICE: ERBE (04050147001930)

Device Identifier (DI) Information

ERBE
20150-300
In Commercial Distribution
20150-300
Erbe Elektromedizin GmbH
04050147001930
GS1

1
316116623 *Terms of Use
Pump cartridge for ERBEJET® 2
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Water jet knife system pump-cartridge A sterile, non-electrical component of a water jet knife system intended to be inserted into the system’s generator to pressurize a fluid medium, typically sterile saline, and conduct the resulting high-pressure stream to the system’s handpiece for soft-tissue cutting and submucosal injection during surgery. It is in the form of a plastic housing containing pistons mechanically powered by the generator; it includes a port for connection to the handpiece, which may facilitate changing of the handpiece intraoperatively. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FQH LAVAGE, JET
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K072404 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

b17e9027-005c-4412-9e01-ebad378a8c41
July 06, 2018
3
October 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04050147015470 5 04050147001930 In Commercial Distribution Level: 1
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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