DEVICE: WEGO-SILK Non-absorbable Surgical Suture With Needle (06941813651253)
Device Identifier (DI) Information
WEGO-SILK Non-absorbable Surgical Suture With Needle
S23903
In Commercial Distribution
Foosin Medical Supplies Inc., Ltd.
S23903
In Commercial Distribution
Foosin Medical Supplies Inc., Ltd.
No description.
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 |
---|---|
Silk suture, sterile | A sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 disposable needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAP | Suture, Nonabsorbable, Silk |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K080684 | 000 |
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
37de6c5e-02ed-4937-b6e6-594aa24f8f5e
July 06, 2018
3
September 28, 2015
July 06, 2018
3
September 28, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
06941813656258 | 12 | 06941813651253 | 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