FDA.reportPublic FDA data

A.C.S® (Alcon Closure System)

Primary DI
10380651896113
Brand
A.C.S® (Alcon Closure System)
Company
Alcon Laboratories, Inc.
Model
8065189611
Device description
Suture - Needle Type T-1,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double Armed
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GASSuture, Nonabsorbable, Synthetic, Polyester

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GASSuture, Nonabsorbable, Synthetic, PolyesterGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880094000DACRON SURGICAL SUTURESAlcon Laboratories1989-09-22GAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380651896113PackageGS112In Commercial Distribution
00380651896116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065189611310380651896113
00380651896116003806518961163806518961160380651896116

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 241-5999web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

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Primary DI, Brand, Company table
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00840124521339TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521346TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521353TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521360TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00850012846543RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
10850012846540RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
00840277408389PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408396PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408402PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
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00840277408426RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408433RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408440RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408457RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409133PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409140PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409416RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409430RiverBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408386PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408393PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408409PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408416PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408423RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408430RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408447RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408454RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409130PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18