Aurolon

GUDID 00803878028875

Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. 8402N model consists of a 10/0 Nylon suture of length 40cm attached with two 200 microns SS needles having the needle length of 6.0mm in both the ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Spatula.

AUROLAB

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 00803878028875
• NIH Device Record Key: e5ba0fa8-4de8-4de7-9600-b25ccbdfc13c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurolon
• Version Model Number: 8402N
• Company DUNS: 677319965
• Company Name: AUROLAB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com
• Phone: +914523096100
• Email: krishna@aurolab.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803878028875 [Primary]
GS1	10803878028872 [Package]; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024090

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-29
• Device Publish Date: 2020-06-20

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