DEVICE: Sutralon (M583N1040611)
Device Identifier (DI) Information
Sutralon
N104061
In Commercial Distribution
VISIONARY MEDICAL SUPPLIES INC
N104061
In Commercial Distribution
VISIONARY MEDICAL SUPPLIES INC
10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 6 inch (15 cm) / Needle Specifications: ST-140-6, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.15 mm / # of needles: Single 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? |
---|---|---|---|---|
38000 | Nylon suture, non-bioabsorbable, monofilament |
A 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K994176 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from chemicals and oxides |
Clinically Relevant Size
[?]Size Type Text |
---|
Angle: 140 degree |
Device Size Text, specify: 10-0 USP |
Outer Diameter: 0.15 Millimeter |
Length: 6.00 Millimeter |
Length: 15 Centimeter |
Device Record Status
e4f706d9-9d82-4a21-8166-7f209a178e5f
February 05, 2021
5
May 13, 2016
February 05, 2021
5
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 |
---|---|---|---|---|---|
M583N1040613 | 12 | M583N1040612 | In Commercial Distribution | Carton | |
M583N1040612 | 1 | M583N1040611 | 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