Aurosilk

GUDID 10803878029077

Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture. B4401 model consists of a 4/0 Braided Silk suture of length 76cm attached with one 430 microns SS needles having the needle length of 15.9mm in both ends of suture. Angle of curvature of the needle is 135° [3/8 Circle]. Point profile of needle is Conventional cutting.

AUROLAB

Silk suture, sterile Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture Silk suture

• Primary Device ID: 10803878029077
• NIH Device Record Key: d1270ca3-829a-4bd4-8f91-105154daf7a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurosilk
• Version Model Number: B4401
• 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

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	00803878029070 [Primary]
GS1	10803878029077 [Package]; Contains: 00803878029070; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024091

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

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: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [Aurosilk]

• 10803878029091: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
• 10803878029084: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
• 10803878029077: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
• 10803878028933: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
• 10803878028902: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl