DEVICE: NA (04055207048627)

Device Identifier (DI) Information

NA
4170954
In Commercial Distribution
4170.954
Richard Wolf GmbH
04055207048627
GS1

10
315304071 *Terms of Use
SUCTION/IRRIGATION TUBE SET L 3M PVC, PACK=10 PCS, with 3mm female Luer lock, for suction irrigation handle 8385.901, sterile, for single use
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Surgical irrigation/aspiration tubing set A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K002000 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 3 Meter
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Device Record Status

057ff1d2-a2c5-425d-a83a-87222338b043
July 06, 2018
3
June 28, 2017
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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
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: 04055207049525 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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