Sutralene

Basic Information

• Brand Name: Sutralene
• Primary DI: M583P540151RC1
• Version / Model: P540151RC
• Company Name: VISIONARY MEDICAL SUPPLIES INC
• Labeler DUNS: 111585795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-14
• Public Version: 6
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 7665963f-f5c8-4cb9-a8fd-af7889050ee4

Device Description

5-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 28 inch (70 cm) / Needle Specifications: RC-130-15, Reverse Cutting, 3/8 circle (140 degrees), length 13.1 mm, wire 0.38 mm / # of needles: single arm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	878.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13909	Polyolefin/fluoropolymer suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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 to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M583P540151RC3	HIBCC	carton	12	In Commercial Distribution
Package	M583P540151RC2	HIBCC	pouch	1	In Commercial Distribution
Primary	M583P540151RC1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K070243	000

Device Sizes

Type	Value	Unit	Text
Angle	140	degree
Device Size Text, specify			5-0 USP
Outer Diameter	0.38	Millimeter
Length	13.1	Millimeter
Length	70	Centimeter