DEVICE: Sutrazorb (M583A660921)
Device Identifier (DI) Information
Sutrazorb
A66092
In Commercial Distribution
VISIONARY MEDICAL SUPPLIES INC
A66092
In Commercial Distribution
VISIONARY MEDICAL SUPPLIES INC
6-0 Suture USP / Thread Specifications: PGA, 18 inch (45 cm) / Needle Specifications: ST-160-9, Spatula Tip, 1/2 (160 degrees), length 8.0 mm, wire 0.23 mm / # of needles: Double arm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
13908 | 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.
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Obsolete | false |
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 |
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Special Storage Condition, Specify: Keep away from moisture, chemicals, oxides, and direct heat. |
Storage Environment Temperature: less than 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 0.23 Millimeter |
Angle: 160 degree |
Length: 8.0 Millimeter |
Length: 45 Centimeter |
Device Size Text, specify: 6-0 USP |
Device Record Status
5c0a088b-75c6-4899-8da4-99a70ff57d0b
March 29, 2018
2
May 13, 2016
March 29, 2018
2
May 13, 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 |
---|---|---|---|---|---|
M583A660923 | 12 | M583A660922 | In Commercial Distribution | carton | |
M583A660922 | 1 | M583A660921 | In Commercial Distribution | pouch |
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
[?]
608-270-3880
info@visionarymedicalsupplies.com
info@visionarymedicalsupplies.com