DEVICE: NA (04055207020388)

Device Identifier (DI) Information

NA
8753008
In Commercial Distribution
8753.008
Richard Wolf GmbH
04055207020388
GS1

1
315304071 *Terms of Use
OUTER SHEATH FOR HYSTEROSCOPE 17.5FR color code white, WL 214mm, oval, working channel 9Fr, compatible with hysteroscopy telescope 8753411, 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 An endoscopic device that is a component of a rigid endoscope assembly shaped as a thin metal tube through which other endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HIH HYSTEROSCOPE (AND ACCESSORIES)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033113 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide
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
Outer Diameter: 5.83333333333 Millimeter
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Device Record Status

f1f7f3f2-0cff-4264-8056-80aa774fd500
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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