FDA.reportPublic FDA data

Aurolon

Primary DI
00803878028899
Brand
Aurolon
Company
AUROLAB
Model
8481N
Device description
Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture.8481N model consists of a 8/0 Nylon suture of length 40cm attached with one 200 microns SS needles having the needle length of 6.0mm in oneend of suture. Angle of curvature of the needle is 140° [3/8 Circle]. Point profile of needle is Spatula.
Published
2020-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K024090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024090000NYLON SUTUREAurolab2003-02-28GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803878028896PackageGS112In Commercial Distribution
00803878028899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080387802889610803878028896
00803878028899008038780288998038780288990803878028899

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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+914523096100krishna@aurolab.com

Regulatory Flags#

DUNS number
677319965
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803878044226CornisolCornisol2023-06-27
10803878053058Aurotrocar ATS-23G2023-06-27
10803878036341NanocutS150022023-06-15
10803878044667AuroSleekC25222HT2023-06-15
10803878053201AuroSlimSK222152023-06-15
00803878028820Aurolon 6601N2020-06-22
00803878028837Aurolon 6602N2020-06-22
00803878028851Aurolon 6692N2020-06-22
00803878028868Aurolon 8401N2020-06-22
00803878028905Aurosilk8481S2020-06-23
00803878028936Aurosilk8482S2020-06-23
00803878029032PolycrylA64092020-12-12
00803878029070AurosilkB44012020-06-23
00803878029087AurosilkB61052020-06-23
00803878029094AurosilkB61062020-06-23
00803878041638PolycrylA51082020-12-12
00803878067249Aurolon 6402N 2020-06-22
00803878029025PolycrylA61082020-09-16
00803878029049PolycrylA71022020-09-16
00803878029063PolycrylA81042020-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
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