Sutrasilk

GUDID M583S440171C3

4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: CT-135-17, Cutting Tip, 3/8 circle (140 degrees), length 15.9 mm, wire 0.43mm / # of needles: Single arm

VISIONARY MEDICAL SUPPLIES INC

Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture

• Primary Device ID: M583S440171C3
• NIH Device Record Key: 654e2234-d6fa-42b5-84f9-ed7a8a5820bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sutrasilk
• Version Model Number: S440171C
• 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

Device Dimensions

• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter
• Angle: 140 degree
• Device Size Text, specify: 0
• Outer Diameter: 0.43 Millimeter
• Length: 15.9 Millimeter
• Length: 76 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M583S440171C1 [Primary]
HIBCC	M583S440171C2 [Package]; Contains: M583S440171C1; Package: pouch [1 Units]; In Commercial Distribution
HIBCC	M583S440171C3 [Package]; Contains: M583S440171C2; Package: carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994177

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-09-06

On-Brand Devices [Sutrasilk]

• M583VS840823: 8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: S
• M583VS840813: 8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: S
• M583S840823: 8-0 Suture USP / Thread Specifications: Silk, Black Braided, 12 inch (30 cm) / Needle Specificat
• M583S74092TP3: 7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specificat
• M583S740923: 7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specificat
• M583S6401123: 6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specificat
• M583S440171C3: 4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specificat