Sutrazorb

Basic Information

• Brand Name: Sutrazorb
• Primary DI: M583A84082TP1
• Version / Model: A84082TP
• Company Name: VISIONARY MEDICAL SUPPLIES INC
• Labeler DUNS: 111585795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c3b2ae05-5e22-4c24-bb0b-590c3c3f980f

Device Description

8-0 Suture USP / Thread Specifications: PGA, 5 inch (13 cm) / Needle Specifications: TP-140-8, Taper Point, 3/8 (140 degrees), length 6.5mm, wire diameter 0.20 mm / # of needles: Double 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
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M583A84082TP3	HIBCC	Carton	12	In Commercial Distribution
Package	M583A84082TP2	HIBCC	Pouch	1	In Commercial Distribution
Primary	M583A84082TP1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.20	Millimeter
Angle	140	degree
Length	6.5	Millimeter
Length	13	Centimeter
Device Size Text, specify			8-0 USP

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from Moisture, chemicals, oxides, and direct heat.
• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius