Aurosilk

GUDID 10803878028933

Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture. 8482S model consists of a 8/0 Braided Silk suture of length 30cm attached with two 200 microns SS needles having the needle length of 6.0mm in both ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Spatula.

AUROLAB

Silk suture, sterile
Primary Device ID10803878028933
NIH Device Record Keya3c1ac4b-0854-4d89-8d7f-dd3153b9dfd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurosilk
Version Model Number8482S
Company DUNS677319965
Company NameAUROLAB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com
Phone+914523096100
Emailkrishna@aurolab.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100803878028936 [Primary]
GS110803878028933 [Package]
Contains: 00803878028936
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAPSuture, Nonabsorbable, Silk

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

On-Brand Devices [Aurosilk]

10803878029091Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
10803878029084Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
10803878029077Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
10803878028933Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl
10803878028902Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainl

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