DEVICE: RELI (00386120006147)
Device Identifier (DI) Information
RELI
MS347-SI
In Commercial Distribution
MYCO MEDICAL SUPPLIES INC.
MS347-SI
In Commercial Distribution
MYCO MEDICAL SUPPLIES INC.
REDICAPRONE-25 Monofilament Poliglecaprone 25, Undyed, 1, MCT-1
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 36 Inch |
Device Size Text, specify: 1 USP |
Device Record Status
b8f575b8-4d71-4ad1-8b29-616bf2c1331a
March 29, 2018
2
October 24, 2015
March 29, 2018
2
October 24, 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 |
---|---|---|---|---|---|
20386120006141 | 30 | 10386120006144 | In Commercial Distribution | Case | |
10386120006144 | 12 | 00386120006147 | In Commercial Distribution | Inner Carton |
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