DEVICE: ERBE (04050147001916)

Device Identifier (DI) Information

ERBE
20150-238
In Commercial Distribution
20150-238
Erbe Elektromedizin GmbH
04050147001916
GS1

1
316116623 *Terms of Use
Applicator w/ suction OD 6mm; L 306mm
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47559 Water jet knife system handpiece, single-use
A sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device.
Active false
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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
K231023 000
No CLOSE

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
Length: 306.000 Millimeter
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Device Record Status

afbf5bdd-a5d3-43cf-91ab-91a062fcd313
February 14, 2024
4
September 14, 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
04050147015456 5 04050147001916 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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