epic edge

Basic Information

• Brand Name: epic edge
• Primary DI: 00855019008017
• Version / Model: N2673
• Company Name: R.K. MANUFACTURING CORPORATION OF CONNECTICUT
• Labeler DUNS: 116162108
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-15
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: b59111d5-8129-4aa3-bfe9-ada621ccbe01

Device Description

10/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device)

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: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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	00855019008017	GS1
Package	10855019008014	GS1	Box	12	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 73 Degrees Fahrenheit