Aurolon

GUDID 00803878030045

Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. These needles are produced in different lengths likely 5.6 mm, 6.2mm, and 6.0mm etc having the suture diameter of 1-0 to 10-0 respectively.

AUROLAB

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 00803878030045
• NIH Device Record Key: ea80fe4d-1ac5-4ca3-88bc-58cdff09ac5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurolon
• Version Model Number: 6401N
• 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: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803878030045 [Primary]
GS1	10803878030042 [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

On-Brand Devices [Aurolon ]

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• 00803878028929: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
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• 10803878028865: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
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• 10803878028827: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl