Noevia - 2xDDK-10-250 USP 6-0 Polypropylene blue 45 cm. - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: 2xDDK-10-250 USP 6-0 Polypropylene blue 45 cm. sterile VA9.7

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More Product Details

Catalog Number

LENE07DC

Brand Name

Noevia

Version/Model Number

LENE07DC

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

K131224,K131224

Product Code Details

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Device Record Status

Public Device Record Key

ee6d67ba-506c-44b1-90f9-2d9acbd52c2d

Public Version Date

August 29, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

10848782042828

Quantity per Package

12

Contains DI Package

00848782042821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 300
2 A medical device with a moderate to high risk that requires special controls. 2030
U Unclassified 19