DEVICE: Monomax (04046963968670)

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Device Identifier (DI) Information

Monomax
B9941117
B9941117
B BRAUN SURGICAL SA
04046963968670
GS1
24
MONOMAX VLT 0(3,5)150CMHR40S USALOOPMDDP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Polybutester suture A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polybutester, a copolymer of polyglycol terephthalate and polytrimethylene terephthalate, intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is very elastic and has a low coefficient of friction, making it ideal for surface closure, and does not lose tensile strength or become absorbed. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NWJ Suture, recombinant technology
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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 0 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Size of Thread (USP - Others) : 0
Device Size Text, specify: Thread Material : polyhydroxibutyrate
Length: 150.00 Centimeter
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Device Status

Not in Commercial Distribution
November 01, 2015
February 23, 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: 04046963968663 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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