A.C.S® (Alcon Closure System)

GUDID 10380652176016

Suture - Needle Type PC-7,Green Monofilament Polyester(GMP), Suture Size 10-0, Suture Length 8,Double Armed

Alcon Laboratories, Inc.

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament
Primary Device ID10380652176016
NIH Device Record Keydb0af854-ebbb-454f-8362-5873c7d29843
Commercial Distribution StatusIn Commercial Distribution
Brand NameA.C.S® (Alcon Closure System)
Version Model Number8065217601
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com
Phone+1 (800) 241-5999
Emailweb.masterus@alcon.com

Device Dimensions

Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100380652176019 [Primary]
GS110380652176016 [Package]
Contains: 00380652176019
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GASSuture, Nonabsorbable, Synthetic, Polyester

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2015-10-24

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

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