DEVICE: ProACT - Replacement Actuator - Tissue Expanding Device II (00180668000144)

Device Identifier (DI) Information

ProACT - Replacement Actuator - Tissue Expanding Device II
750043
In Commercial Distribution

UROMEDICA INC
00180668000144
GS1

1
080378479 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
No
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
Hydraulic incontinence treatment system An assembly of implanted devices used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. It typically consists of a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface, that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate the pad or cuff to compress the urethra.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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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

ebc91e8e-ef69-4985-b05d-e72a14259128
March 29, 2018
2
July 15, 2016
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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
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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