Aurolon

Basic Information

• Brand Name: Aurolon
• Primary DI: 00803878028868
• Version / Model: 8401N
• Company Name: AUROLAB
• Labeler DUNS: 677319965
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-22
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: baf954a1-a5c0-4306-a868-98724acb1553

Device Description

Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. 8401N model consists of a 10/0 Nylon suture of length 40cm attached with one 200 microns SS needles having the needle length of 6.0mm in one end of suture. Angle of curvature of the needle is are 140° [3/8 Circle]. Point profile of needle is Spatula.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
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
Package	10803878028865	GS1	Box	12	In Commercial Distribution
Primary	00803878028868	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024090	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 40 Degrees Celsius