Long microsaw blade 21x0,6mm - Bien-Air Surgery SA

Duns Number:481597719

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More Product Details

Catalog Number

1502681-001

Brand Name

Long microsaw blade 21x0,6mm

Version/Model Number

1502681

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

Yes

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

DWH

Product Code Name

Blade, Saw, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

06a20a96-0e84-4a2e-b610-20b90713a0e5

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

February 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIEN-AIR SURGERY SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 69