DEVICE: NA (04055207023396)

Device Identifier (DI) Information

NA
8968015
In Commercial Distribution
8968.015
Richard Wolf GmbH
04055207023396
GS1

1
315304071 *Terms of Use
DILATOR 15FR for "One-Step" - Bougie application, TL 320mm, cannulated, 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 dilator, reusable A device used to dilate a lumen in order to enable or ease the introduction of endoscopic instruments into this cavity. The dilatation can be carried out, e.g., through the skin layer (percutaneously), in the urethra or in the ureter. It may be a flexible or rigid rod or tube with a tapered distal tip. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
KOE DILATOR, URETHRAL
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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 [?]
Hydrogen Peroxide
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
Lumen/Inner Diameter: 5 Millimeter
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Device Record Status

8495873a-14e3-4012-aa1c-c8f4bc37bcd2
March 29, 2018
2
September 23, 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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