STILLE Awls - AWL STILLE 17 cm 6.75 in - Stille AB

Duns Number:355280827

Device Description: AWL STILLE 17 cm 6.75 in

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More Product Details

Catalog Number

111-19381

Brand Name

STILLE Awls

Version/Model Number

111-19381

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)

-

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

HTF

Product Code Name

Curette

Device Record Status

Public Device Record Key

ca98402a-dc03-4271-999e-4164454091c3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STILLE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1073
2 A medical device with a moderate to high risk that requires special controls. 17