DEVICE: Oasis (B031MVZ3320)

Device Identifier (DI) Information

Oasis
MV-Z332
In Commercial Distribution

American Health Service Sales Corporation
B031MVZ3320
HIBCC

1
556115970 *Terms of Use
SUTURE,PDO,3-0,NCT-2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polydioxanone suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] 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 extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NEW Suture, Surgical, Absorbable, Polydioxanone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K073614 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

be46d33a-9551-4382-8926-d3b182e791c0
July 06, 2018
3
January 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B031MVZ3321 12 B031MVZ3320 In Commercial Distribution
B031MVZ3322 100 B031MVZ3321 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

[?]
No Customer Contact currently defined
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