DEVICE: Bardex® Angle Drain Four-Wing Malecot Type (00801741076855)

Device Identifier (DI) Information

Bardex® Angle Drain Four-Wing Malecot Type
09203024
In Commercial Distribution
09203024
C. R. Bard, Inc.
00801741076855
GS1

1
016898496 *Terms of Use
Bardex® Angle Drain Four-Wing Malecot Type
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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?
34924 Suprapubic drainage catheter
A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FEW Catheter, malecot
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FDA Premarket Submission

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

[?]
Size Type Text
Catheter Gauge: 24 French
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Device Record Status

18b4e406-d19a-4a3d-a257-06ed6d202613
May 16, 2024
3
July 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
10801741076852 6 00801741076855 In Commercial Distribution CA
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)526-4455
medical.services@crbard.com
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