A.C.S® (Alcon Closure System) - Suture - Needle Type C-3, Methylene Blue-Dyed - Alcon Laboratories, Inc.

Duns Number:008018525

Device Description: Suture - Needle Type C-3, Methylene Blue-Dyed Silk(MBDS), Suture Size 8-0, Suture Length 1 Suture - Needle Type C-3, Methylene Blue-Dyed Silk(MBDS), Suture Size 8-0, Suture Length 18, Double Armed

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More Product Details

Catalog Number

-

Brand Name

A.C.S® (Alcon Closure System)

Version/Model Number

8065203801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K760158,K760158

Product Code Details

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Device Record Status

Public Device Record Key

b4431428-6481-466d-99a5-3670ee53cc41

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

10380652038017

Quantity per Package

12

Contains DI Package

00380652038010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"ALCON LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 250
2 A medical device with a moderate to high risk that requires special controls. 541
3 A medical device with high risk that requires premarket approval 6098