DEVICE: Clear Advantage Male Continence Sheath (00801741070624)
Device Identifier (DI) Information
Clear Advantage Male Continence Sheath
3243
In Commercial Distribution
3243
C. R. Bard, Inc.
3243
In Commercial Distribution
3243
C. R. Bard, Inc.
Clear Advantage with Aloe Clear Silicone Self-Adhesive Male Continence Sheath
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
34929 | Urinary incontinence penis sheath/port, single-use |
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NNX | DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 24 Millimeter |
Device Record Status
7f54c26a-ef73-47d0-bdca-0a66886f2a6d
June 10, 2022
2
September 22, 2020
June 10, 2022
2
September 22, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10801741070621 | 30 | 00801741070624 | In Commercial Distribution | CA | |
20801741070628 | 360 | 10801741070621 | In Commercial Distribution | CA |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)526-4455
medical.services@crbard.com
medical.services@crbard.com