DEVICE: RIWO-ART (04055207022269)

Device Identifier (DI) Information

RIWO-ART
8921125
In Commercial Distribution
8921.125
Richard Wolf GmbH
04055207022269
GS1

1
315304071 *Terms of Use
TROCAR TIP TRIANGULAR SZ 5.5MM WL 219MM distal tip triangular, reusable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Laparoscopic trocar blade, reusable A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
FBQ Trocar, gastro-urology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K932441 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
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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: 219 Millimeter
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Device Record Status

9b03d926-126d-4cee-b948-9f3ef0f7fa83
July 06, 2018
3
September 27, 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
No Package DIs found
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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
No
No
No CLOSE

Customer Contact

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