FDA.reportPublic FDA data

Polycryl

Primary DI
10803878041635
Brand
Polycryl
Company
AUROLAB
Model
A5108
Device description
Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A5108 model consists of a 5/0 PGA suture of length 45cm attached with two 330 microns SS needles having the needle length of 8.0mm in both the ends of suture. Angle of curvature of both the needles are 90° [1/4 Circle]. Point profile of both needles are Spatula.
Published
2020-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140039000POLYCRYLAurolab2014-09-15GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803878041635PackageGS112In Commercial Distribution
00803878041638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080387804163510803878041635
00803878041638008038780416388038780416380803878041638

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
677319965
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
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
00803878028899Aurolon 8481N2020-06-22
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

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