Quinelato - Obwegeser AWLS 23cm - Schobell Industrial Ltda

Duns Number:899060826

Device Description: Obwegeser AWLS 23cm

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More Product Details

Catalog Number

QD.247.23

Brand Name

Quinelato

Version/Model Number

QD.247.23

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

-

Product Code Details

Product Code

GDM

Product Code Name

Needle, Aspiration And Injection, Reusable

Device Record Status

Public Device Record Key

6fb519d9-e776-4688-bd9c-a92738ca6a2c

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHOBELL INDUSTRIAL LTDA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 545