STILLE Osteotomes - HAND OSTEOTOME STILLE 12 mm curved blade R45 mm - Stille AB

Duns Number:355280827

Device Description: HAND OSTEOTOME STILLE 12 mm curved blade R45 mm phenolic handle 16 cm 6.25 in

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More Product Details

Catalog Number

100-111-0084

Brand Name

STILLE Osteotomes

Version/Model Number

100-111-0084

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

KDG

Product Code Name

Chisel (Osteotome)

Device Record Status

Public Device Record Key

dd2e2f1a-4938-4048-b06a-1c5f6771d2d6

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 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