FDA.reportPublic FDA data

A.C.S® (Alcon Closure System)

Primary DI
10380656930010
Brand
A.C.S® (Alcon Closure System)
Company
Alcon Laboratories, Inc.
Model
8065693001
Device description
Suture - Needle Type A-3,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Double Armed
Published
2015-10-24
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
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930517000NON-ABSORBABLE SURGICAL SUTURESAlcon Laboratories1993-12-17GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380656930010PackageGS112In Commercial Distribution
00380656930013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065693001010380656930010
00380656930013003806569300133806569300130380656930013

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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
Length12Inch

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
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052516SharpointSurgical Specialties México, S. de R.L. de C.V.GAR2026-08-26
10705031089020ETHILONETHICON, LLCGAR2026-08-25
10705031096479ETHILONETHICON, LLCGAR2026-08-25
00816848022964SUPRAMIDS JACKSON INCGAR2026-08-21
00816848022988SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023008SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023329SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023343SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023367SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023381SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023527SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023541SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023664SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023688SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023787SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023800SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023824SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023848SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023862SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023886SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023947SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023954SUPRAMIDS JACKSON INCGAR2026-08-21
00816848024029SUPRAMIDS JACKSON INCGAR2026-08-21
08903837402325TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
08903837799326TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
10705031245587ETHILONETHICON, LLCGAR2026-08-17
10705031245624ETHILONETHICON, LLCGAR2026-08-17
10705031465374ETHILONETHICON, LLCGAR2026-08-17
10705031465381ETHILONETHICON, LLCGAR2026-08-17
10705031465404ETHILONETHICON, LLCGAR2026-08-17