SURGICAL INSTRUMENT - DRIVER HAND HEX 1.2X20 - Sin Sistema de Implante Nacional S/A

Duns Number:904569092

Device Description: DRIVER HAND HEX 1.2X20

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More Product Details

Catalog Number

CDH 1220

Brand Name

SURGICAL INSTRUMENT

Version/Model Number

CDH 1220

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

-

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

K201688

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

a9e7ba46-373d-4e2f-ac46-691e8fa9fd84

Public Version Date

April 06, 2021

Public Version Number

1

DI Record Publish Date

March 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIN SISTEMA DE IMPLANTE NACIONAL S/A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1337