DEVICE: Oasis (B031MV86650)
Device Identifier (DI) Information
Oasis
MV-8665
In Commercial Distribution
American Health Service Sales Corporation
MV-8665
In Commercial Distribution
American Health Service Sales Corporation
SUTURE,POLYPROPYLENE,3-0,NFS-2
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAW | Suture, Nonabsorbable, Synthetic, Polypropylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a0680410-cdf7-4307-8984-c385aafa1e51
March 29, 2018
2
January 14, 2016
March 29, 2018
2
January 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined