Sutralene

GUDID M583P90060623

9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm AND Needle Specifications: ST-160-6, Spatula Tip, ½ circle (160 degrees), length 6.2 mm, wire 0.15 mm / # of needles: Double arm

VISIONARY MEDICAL SUPPLIES INC

Polyolefin suture, monofilament

• Primary Device ID: M583P90060623
• NIH Device Record Key: 60f2b518-d41d-495c-ae3e-81d4f2060d58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sutralene
• Version Model Number: P9006062
• Company DUNS: 111585795
• Company Name: VISIONARY MEDICAL SUPPLIES INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com
• Phone: 608-270-3880
• Email: info@visionarymedicalsupplies.com

Device Dimensions

• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter
• Angle: 160 degree
• Angle: 0 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.15 Millimeter
• Length: 6.2 Millimeter
• Length: 16 Millimeter
• Length: 30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M583P90060621 [Primary]
HIBCC	M583P90060622 [Package]; Contains: M583P90060621; Package: Pouch [1 Units]; In Commercial Distribution
HIBCC	M583P90060623 [Package]; Contains: M583P90060622; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070243

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-06-14

On-Brand Devices [Sutralene]

• M583P990623: 9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Need
• M583P90090623: 9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Need
• M583P9006223: 9-0 Suture USP / Thread Specifications: Polypropylene, Monofilament, 5 cm / Needle Specification
• M583P900623: 9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needl
• M583P90060623: 9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Need
• M583P540151RC3: 5-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 28 inch (70 cm) / Need
• M583P109062TP3: 10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Need
• M583P1000623: 10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Need