CROWNJUN Nylon Suture

Basic Information

• Brand Name: CROWNJUN Nylon Suture
• Primary DI: 04946585284069
• Version / Model: NDOKA8
• Catalog Number: NDOKA8
• Company Name: KONO SEISAKUSHO CO.,LTD.
• Labeler DUNS: 691486468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-20
• Public Version: 1
• Public Version Date: 2021-08-30
• Public Version Status: New
• Public Device Record Key: 0e4e3b53-1c11-4f92-a4c3-db31d9daca3d

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: No
• 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
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	878.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38000	Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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
Primary	04946585284069	GS1
Package	14946585284066	GS1		12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K192420	000