DEVICE: Titan (05708932487542)

Device Identifier (DI) Information

Titan
ESR818
In Commercial Distribution
ESR818
Coloplast A/S
05708932487542
GS1

1
305524696 *Terms of Use
Infrapubic OTR Zero Degree Angle Cylinder Set with Pump
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Device Characteristics

MR Conditional
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36250 Inflatable penile prosthesis
An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
FHW Device, Impotence, Mechanical/Hydraulic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000006 001
P000006 002
P000006 024
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep out of sunlight
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Clinically Relevant Size

[?]
Size Type Text
Length: 18 Centimeter
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Device Record Status

38179a20-5210-4742-94ec-233172958a33
July 06, 2018
3
July 21, 2014
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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
Yes
No
No CLOSE

Customer Contact

[?]
8002583476
urology@coloplast.com
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