A.C.S® (Alcon Closure System)

GUDID 00380652080019

Suture - Needle Type CU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Single Armed

Alcon Laboratories, Inc.

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 00380652080019
• NIH Device Record Key: d54c5ed8-12af-44c0-9a47-ba8b4a293dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.C.S® (Alcon Closure System)
• Version Model Number: 8065208001
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com
• Phone: 800-241-5999
• Email: web.masterus@alcon.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380652080019 [Primary]
GS1	10380652080016 [Package]; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930517

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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-10-24

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

• 10380657122018: Suture - Needle Type NU-S,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Singl
• 00380657121014: Suture - Needle Type NU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380657117014: Suture - Needle Type NU-l,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380657104014: Suture - Needle Type AU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Singl
• 10380657100016: Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Singl
• 10380657021014: Suture - Needle Type AU-8,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380657020017: Suture - Needle Type AU-8,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8,Doubl
• 10380656987014: Suture - Needle Type AU-1,Methylene Blue-Dyed Silk(MBDS), Suture Size 8-0, Suture Length 18,Doub
• 10380656986017: Suture - Needle Type AU-1,Methylene Blue-Dyed Silk(MBDS), Suture Size 9-0, Suture Length 18,Doub
• 10380656980015: Suture - Needle Type AU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380656931017: Suture - Needle Type A-3,Black Monofilament Nylon(BMN), Suture Size 9-0, Suture Length 12, Doubl
• 10380656930010: Suture - Needle Type A-3,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Doub
• 10380656921018: Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Dou
• 10380656920011: Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, ,Suture Length 6,Doub
• 10380656919015: Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 8-0, Suture Length 12,Doubl
• 10380653080015: Suture - Needle Type SC-5,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 8,Double Arme
• 10380653079019: Suture - Needle Type PC-9,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 8,Looped
• 10380653076018: Suture - Needle Type PC-7,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 8,Double Arme
• 10380653067016: Suture - Needle Type AU-5,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 12,Double Arm
• 10380653064015: Suture - Needle Type AU-1,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 12,Double Arm
• 10380652221013: Suture - Needle Type CU-5C,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Dou
• 10380652186015: Suture - Needle Type SU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380652177013: Suture - Needle Type R-7,White Braided Silk(WBS), Suture Size 4-0, Suture Length 18,Double Armed
• 10380652176016: Suture - Needle Type PC-7,Green Monofilament Polyester(GMP), Suture Size 10-0, Suture Length 8,D
• 10380652155011: Suture - Needle Type R-5,Black Monofilament Nylon(BMN), Suture Size 5-0, Suture Length 18,Double
• 10380652152010: Suture - Needle Type R-5,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double
• 10380652151013: Suture - Needle Type R-5,White Braided Polyester(WBP), Suture Size 5-0, Suture Length 18,Double
• 10380652132012: Suture - Needle Type R-3,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double
• 10380652131015: Suture - Needle Type R-3,White Braided Polyester(WBP), Suture Size 5-0, Suture Length 18,Double
• 10380652115015: Suture - Needle Type R-1,Black Monofilament Nylon(BMN), Suture Size 5-0, Suture Length 18,Double
• 10380652112014: Suture - Needle Type R-1,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double
• 10380652111017: Suture - Needle Type R-1,White Braided Polyester(WBP), Suture Size 5-0, Suture Length 18,Double
• 10380652081013: Suture - Needle Type C-3,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Singl
• 00380652080019: Suture - Needle Type CU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Sing
• 10380652053010: Suture - Needle Type C-3,Black Braided Silk(BBS), Suture Size 6-0, Suture Length 18,Double Armed
• 10380652038017: Suture - Needle Type C-3, Methylene Blue-Dyed Silk(MBDS), Suture Size 8-0, Suture Length 18, Dou
• 10380652021019: Suture - Needle Type CU-8, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Do
• 10380652020012: Suture - Needle Type CU-8, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8, Dou
• 10380652017012: Suture - Needle Type CUM-15, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,
• 10380652012017: Suture - Needle Type CU-15, Black Monofilament Nylon(BMN), Suture Size 11-0, Suture Length 12, D
• 00380651987012: Suture - Needle Type CU-1, Methylene Blue-Dyed Silk(MBDS), Suture Size 8-0, Suture Length 18, Do
• 10380651986012: Suture - Needle Type CU-1, Methylene Blue-Dyed Silk(MBDS), Suture Size 9-0, Suture Length 18, Do
• 10380651985015: Suture - Needle Type CU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Doubl
• 10380651982014: Suture - Needle Type CU-2,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380651981017: Suture - Needle Type CU-1,Black Monofilament Nylon(BMN), Suture Size 9-0, Suture Length 12,Doubl
• 10380651980010: Suture - Needle Type CU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Doub
• 10380651963013: Suture - Needle Type C-5,Black Braided Silk(BBS), Suture Size 8-0, Suture Length 12,Double Armed
• 10380651956015: Suture - Needle Type B-1,Black Braided Silk(BBS), Suture Size 6-0, Suture Length 18,Double Armed
• 10380651942018: Suture - Needle Type C-4,Black Monofilament Nylon(BMN), Suture Size 8-0, Suture Length 12,Double
• 10380651941011: Suture - Needle Type C-4,Black Monofilament Nylon(BMN), Suture Size 8-0, Suture Length 12,Double