2-0 Uni Pdo 15cm - 2-0 Uni Pdo 15cm - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: 2-0 Uni Pdo 15cm

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More Product Details

Catalog Number

-

Brand Name

2-0 Uni Pdo 15cm

Version/Model Number

VLP-2022

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

K123877,K123877

Product Code Details

Product Code

NEW

Product Code Name

SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Device Record Status

Public Device Record Key

657c8c83-0e68-4aae-aa4c-4cfb27eb0fe3

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10848782023674

Quantity per Package

12

Contains DI Package

00848782023677

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