DEVICE: Oasis (B031MV86650)

Device Identifier (DI) Information

Oasis
MV-8665
In Commercial Distribution

American Health Service Sales Corporation
B031MV86650
HIBCC

1
556115970 *Terms of Use
SUTURE,POLYPROPYLENE,3-0,NFS-2
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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
Polypropylene suture A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polypropylene, an isostatic crystalline stereoisomer of a linear propylene polymer, 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; as the material does not adhere to tissues, it is typically used in cases where the suture is to be removed after healing. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K080684 000
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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
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

a0680410-cdf7-4307-8984-c385aafa1e51
July 06, 2018
3
January 14, 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
B031MV86651 12 B031MV86650 In Commercial Distribution
B031MV86652 100 B031MV86651 In Commercial Distribution
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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