STILLE Various Instruments - GUIDE/DURA PROTECTOR for Wire Saws STILLE-GIGLI - Stille AB

Duns Number:355280827

Device Description: GUIDE/DURA PROTECTOR for Wire Saws STILLE-GIGLI 34 cm 13 in

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More Product Details

Catalog Number

125-19170

Brand Name

STILLE Various Instruments

Version/Model Number

125-19170

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

dd8bb183-fe87-4a11-93be-1a99e91927fe

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 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