FDA.reportPublic FDA data

AROSmicro Suture Sterile

Primary DI
10818245020274
Brand
AROSmicro Suture Sterile
Company
AROS SURGICAL INSTRUMENTS CORPORATION
Model
T6A08N14
Catalog number
T6A08N14
Device description
AROSuture-Sterile 8-0, 140 Microns, MET Point, 5 inches, 6mm, Box/12
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818245020274PrimaryGS10
00818245020277Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081824502027410818245020274
00818245020277008182450202778182450202770818245020277

GMDN Terms#

Term, Definition table
TermDefinition
Vascular clamp, single-useA sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(949)640-9932fred@arosurgical.com

Regulatory Flags#

DUNS number
883777989
Device count
12
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818245020007AROSurgical Vein Vascular ClampTKF-1-15gTKF-1-15g2016-11-18
10818245020014AROSurgical Vein Vascular ClampTKF-1-20gTKF-1-20g2016-11-18
10818245020021AROSurgical Artery Vascular ClampTKF-1-30gTKF-1-30g2016-11-18
10818245020038AROSurgical Artery Vascular ClampTKF-1-40gTKF-1-40g2016-11-18
10818245020045AROSurgical Vein Vascular ClampTKF-2-15gTKF-2-15g2016-11-18
10818245020052AROSurgical Vein Vascular ClampTKF-2-20gTKF-2-20g2016-11-18
10818245020069AROSurgical Artery Vascular ClampTKF-2-30gTKF-2-30g2016-11-18
10818245020076AROSurgical Artery Vascular ClampTKF-2-40gTKF-2-40g2016-11-18
10818245020083AROSurgical Artery Vascular ClampTKL-1-120gTKL-1-120g2016-11-18
10818245020090AROSurgical Vein Vascular ClampTKL-1-60gTKL-1-60g2016-11-18
10818245020106AROSurgical Artery Vascular ClampTKL-2-120gTKL-2-120g2016-11-18
10818245020113AROSurgical Vein Vascular ClampTKL-2-60gTKL-2-60g2016-11-18
10818245020120AROSurgical Vein Vascular ClampTKM-1-30gTKM-1-30g2016-11-18
10818245020137AROSurgical Artery Vascular ClampTKM-1-60gTKM-1-60g2016-11-18
10818245020144AROSurgical Vein Vascular ClampTKM-2-30gTKM-2-30g2016-11-18
10818245020151AROSurgical Artery Vascular ClampTKM-2-60gTKM-2-60g2016-11-18
10818245020168AROSurgical Vein Vascular ClampTKS-1-20gTKS-1-20g2016-11-18
10818245020175AROSurgical Artery Vascular ClampTKS-1-40gTKS-1-40g2016-11-18
10818245020182AROSurgical Vein Vascular ClampTKS-2-20gTKS-2-20g2016-11-18
10818245020199AROSurgical Artery Vascular ClampTKS-2-40gTKS-2-40g2016-11-18

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