Quill

Basic Information

• Brand Name: Quill
• Primary DI: 00848782040193
• Version / Model: VLO-4224
• Catalog Number: VLO-4224
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Labeler DUNS: 812762226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-05
• Public Version: 1
• Public Version Date: 2021-04-13
• Public Version Status: New
• Public Device Record Key: aa0b0cb2-0a25-441d-8454-fa7b1f917dc4

Device Description

Polypropylene,Blue,1,15cm,Taper Point,CT-2,Uni-Directional

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: No
• 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
64255	Barbed polyolefin suture	A single-strand (monofilament), synthetic, non-bioabsorbable thread made from a polyolefin (e.g., polypropylene) intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, after which it is cut and removed. It does not include antimicrobial 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	10848782040190	GS1	Box	12	In Commercial Distribution
Primary	00848782040193	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151112	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 USP