DEVICE: NA (04055207017500)

Device Identifier (DI) Information

NA
8475031
In Commercial Distribution
8475.031
Richard Wolf GmbH
04055207017500
GS1

1
315304071 *Terms of Use
SUCT./IRRIG. TUBE OD 6.2MM WL 128MM for use with suction-irrigation handle 8475.26 and telescopes 8880.541 and 8880.543, straight, 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
Rigid endoscope sheath, reusable A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
EOB NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
Hydrogen Peroxide
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Storage and Handling

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

[?]
Size Type Text
Outer Diameter: 6.2 Millimeter
Length: 128 Millimeter
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Device Record Status

be56e59f-4f95-4509-8d5c-c75e1b91ce2f
September 21, 2018
5
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)

[?]
Yes
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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