DEVICE: Durasphere ® EXP (00858015005011)

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Device Identifier (DI) Information

Durasphere ® EXP
890-216
890-216
Carbon Medical Technologies, Inc.
00858015005011
GS1
1
Injectable Bulking Agent
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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
Urinary tract reconstructive material, non-bioabsorbable A sterile, implantable, non-bioabsorbable synthetic material (e.g., hydrophilic polyacrylamide gel) intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR). It is in the form of a gel material typically preloaded in a disposable syringe and is implanted using an endoscope and/or other dedicated instruments.
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FDA Product Code

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Product Code Product Code Name
LNM Agent, Bulking, Injectable For Gastro-Urology Use
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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
Special Storage Condition, Specify: Does not require refrigeration
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Total Volume: 3 Milliliter
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Device Status

In Commercial Distribution
September 17, 2014

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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8882070262
info@carbonmed.com
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