Dscm19 4-0 Und Mnd 10"/25cm - Dscm19 4-0 Und Mnd 10"/25cm - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: Dscm19 4-0 Und Mnd 10"/25cm

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More Product Details

Catalog Number

-

Brand Name

Dscm19 4-0 Und Mnd 10"/25cm

Version/Model Number

YP-823S

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

c584c306-6e5e-45dd-8517-fe2225af2163

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 22, 2015

Additional Identifiers

Package DI Number

10848782022653

Quantity per Package

12

Contains DI Package

00848782022656

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