Dgl24 4-0 Und Mnd 18"/45cm - Dgl24 4-0 Und Mnd 18"/45cm - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: Dgl24 4-0 Und Mnd 18"/45cm

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More Product Details

Catalog Number

YD-682

Brand Name

Dgl24 4-0 Und Mnd 18"/45cm

Version/Model Number

YD-682N

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

-

Product Code Details

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

011b7b14-c209-46ec-93c0-032090fb2f1f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 22, 2015

Additional Identifiers

Package DI Number

10848782022424

Quantity per Package

12

Contains DI Package

00848782022427

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