DEVICE: NA (04055207022849)

Device Identifier (DI) Information

NA
8934951
In Commercial Distribution
8934.951
Richard Wolf GmbH
04055207022849
GS1

1
315304071 *Terms of Use
GUIDE ROD 5MM TL 500MM 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
Endoscopic-access dilator, reusable A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K942201 000
No CLOSE

Sterilization

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

434b4a66-e736-47f5-9a08-3b5aec8ce04d
July 06, 2018
4
September 28, 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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