Sutrazorb

Basic Information

• Brand Name: Sutrazorb
• Primary DI: M583A7409211
• Version / Model: A74092-1
• Company Name: VISIONARY MEDICAL SUPPLIES INC
• Labeler DUNS: 111585795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cbe61a7a-dc99-4017-bb5a-8055305e8407

Device Description

7-0 Suture USP / Thread Specifications: PGA, 12 inch (30 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 (140 degrees), length 6.5 mm, wire 0.23 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
Primary	M583A7409211	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.5	Millimeter
Length	30	Centimeter
Outer Diameter	0.23	Millimeter
Device Size Text, specify			7-0 USP
Angle	140	degree

Storage Conditions

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