A.C.S® (Alcon Closure System), PAIR-PAK II®

GUDID 10380653054016

Suture 1 - Needle Type A-3, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8" / Suture 2 - Needle Type PC-5, Black Braided Silk(BBS), Suture Size 4-0, Suture Lenght 12"

Alcon Laboratories, Inc.

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 10380653054016
• NIH Device Record Key: dd8ff096-a47f-4509-badb-fff9d14279ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.C.S® (Alcon Closure System), PAIR-PAK II®
• Version Model Number: 8065305401
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com
• Phone: +1 (800) 241-5999
• Email: web.masterus@alcon.com

Device Dimensions

• Length: 8 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch
• Length: 12 Inch
• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380653054019 [Primary]
GS1	10380653054016 [Package]; Contains: 00380653054019; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760158

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-02
• Device Publish Date: 2015-10-24

On-Brand Devices [A.C.S® (Alcon Closure System), PAIR-PAK II® ]

• 10380653072010: Suture 1 - Needle Type CU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12"
• 10380653054016: Suture 1 - Needle Type A-3, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8" /
• 10380653052012: "Suture 1 - Needle Type AU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8"
• 10380653049012: Suture - Needle Type AUM-5, SC-5,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 12, Do