DEVICE: WEGO-PGA Absorbable Surgical Suture With Needle (06941813602422)
Device Identifier (DI) Information
WEGO-PGA Absorbable Surgical Suture With Needle
G33193
In Commercial Distribution
Foosin Medical Supplies Inc., Ltd.
G33193
In Commercial Distribution
Foosin Medical Supplies Inc., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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 |
---|---|
Polyglycolic acid suture | A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K073614 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c962c5e7-5d56-4390-b0f5-3f5102ada0a8
July 06, 2018
3
December 07, 2015
July 06, 2018
3
December 07, 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 |
---|---|---|---|---|---|
6941813692423 | 12 | 06941813602422 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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