DEVICE: Wellead Urethral Dilator (06936881136429)

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Device Record History
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Device Identifier (DI) Information
Wellead Urethral Dilator
U02A081610
In Commercial Distribution

Well Lead Medical Co.,Ltd
06936881136429
GS1

1
544811862 *Terms of Use
Urethral Dilator Straight, Hydrophilic coated 16Fr
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64677 Urethral dilator, single-use
A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a single-use device.
Active false
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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
Yes CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status
105ea6f9-8ed6-425d-8f31-884cf8973ce0
July 20, 2023
1
July 12, 2023
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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
16936881136426 5 06936881136429 In Commercial Distribution Box
26936881136423 10 16936881136426 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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