DEVICE: Oasis (B031MVY3450)

Device Identifier (DI) Information

Oasis
MV-Y345
In Commercial Distribution

American Health Service Sales Corporation
B031MVY3450
HIBCC

1
556115970 *Terms of Use
SUTURE, MONOFYL, 2-0, NCT-1
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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
Poliglecaprone suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) 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, 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
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130737 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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

d4aefc5b-619c-4255-9fc2-8443478375d7
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
B031MVY3451 12 B031MVY3450 In Commercial Distribution
B031MVY3452 100 B031MVY3451 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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