Polycryl

GUDID 10803878029039

Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6409 model consists of a 6/0 PGA suture of length 45cm attached with two 510 microns SS needles having the needle length of 20.0mm in one end of suture. Angle of curvature of both the needles are 135° [3/8 Circle]. Point profile of needle is Conventional Cutting.

AUROLAB

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 10803878029039
• NIH Device Record Key: 48792361-d38b-480c-8d94-2a290643efa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polycryl
• Version Model Number: A6409
• 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
• 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
• Handling Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803878029032 [Primary]
GS1	10803878029039 [Package]; Contains: 00803878029032; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140039

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

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: 2020-12-21
• Device Publish Date: 2020-12-12

On-Brand Devices [Polycryl]

• 00803878029063: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless
• 00803878029049: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless
• 00803878029025: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless
• 10803878041635: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless
• 10803878029039: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless