Aurosilk

Basic Information

• Brand Name: Aurosilk
• Primary DI: 00803878028905
• Version / Model: 8481S
• Company Name: AUROLAB
• Labeler DUNS: 677319965
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-23
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 9d3d411a-0d36-462c-a05a-9ac0082c1a9a

Device Description

Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture. 8481S model consists of a 8/0 Braided Silk suture of length 15cm 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 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
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	878.5030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13910	Silk suture	A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10803878028902	GS1	Box	12	In Commercial Distribution
Primary	00803878028905	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024091	000

Storage Conditions

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