DEVICE: MANI Sutures Nylon (04546951402471)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 |
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Nylon suture, monofilament | A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., 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 can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
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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Device Size Text, specify: Needle Length 6.0mm |
Device Size Text, specify: Suture Length 30cm |
Device Record Status
aa292c26-3373-4f4f-bcd3-ab938f49621a
March 29, 2018
2
June 04, 2016
March 29, 2018
2
June 04, 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 |
---|---|---|---|---|---|
14546951402478 | 12 | 04546951402471 | 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