DEVICE: Virtue (05708932499149)

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Device Identifier (DI) Information

Virtue
50020
50020
Coloplast A/S
05708932499149
GS1
1
Male Sling System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Male stress urinary incontinence surgical mesh A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted to support and/or reposition the urethra without causing obstruction or compression of the urethral lumen for the treatment of male stress urinary incontinence (SUI). It may be available with various material attributes (e.g., shape, weave), and may include a tensioning suture (this may be bioabsorbable); it may be referred to as a suburethral sling. Disposable devices associated with implantation (e.g., transobturator needles) may be included.
Suture/needle passer, single-use A sterile, hand-held, manual surgical instrument designed for passing (driving) sutures and suture needles through tissues/prosthetic materials to facilitate suturing. A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OTM Mesh, surgical, for stress urinary incontinence, male
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 22, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)258-3476
urology@coloplast.com
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