DEVICE: ProACT - Implantation Instrument Set (00180668000106)

Device Identifier (DI) Information

ProACT - Implantation Instrument Set
750041
In Commercial Distribution

UROMEDICA INC
00180668000106
GS1

1
080378479 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
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 male urinary incontinence treatment system An assembly of implantable devices intended to treat male urinary incontinence by applying pressure to partially/fully occlude the bladder neck and/or urethra, typically after radical prostatectomy or transurethral resection of the prostate. It typically consists of an inflatable pad-like device(s) (e.g., cushion, balloon) implanted around the bladder neck/urethra, port and tubing for the introduction/removal of fluid (e.g. saline) to/from the pad(s) intra- and/or postoperatively, and devices for the stabilization of the pad(s) in situ (e.g., sutures, mesh); devices for the introduction/removal of fluid via the port (e.g., needles) may also be included.
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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

b23d88e7-8d52-49c2-b9a1-e9dcc782e8be
January 23, 2019
3
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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