DEVICE: ERBE (04050147001916)
Device Identifier (DI) Information
ERBE
20150-238
In Commercial Distribution
20150-238
Erbe Elektromedizin GmbH
20150-238
In Commercial Distribution
20150-238
Erbe Elektromedizin GmbH
Applicator w/ suction OD 6mm; L 306mm
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FQH | LAVAGE, JET |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K072404 | 000 |
K231023 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Keep away from heat and direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 306.000 Millimeter |
Device Record Status
afbf5bdd-a5d3-43cf-91ab-91a062fcd313
February 14, 2024
4
September 14, 2016
February 14, 2024
4
September 14, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4970717550
info@erbe-med.com
info@erbe-med.com