Oscillating Saw Blade - Oscillating Saw Blade - for Linvatec® Hall® - Gebr. Brasseler GmbH & Co. KG

Duns Number:317409001

Device Description: Oscillating Saw Blade - for Linvatec® Hall® 100x25x1.27mm

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More Product Details

Catalog Number

05.003.639S

Brand Name

Oscillating Saw Blade

Version/Model Number

05.003.639S

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

GFA

Product Code Name

Blade, Saw, General & Plastic Surgery, Surgical

Device Record Status

Public Device Record Key

50176e4d-ded7-4535-a68e-474cf6ece9ee

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEBR. BRASSELER GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 154
2 A medical device with a moderate to high risk that requires special controls. 70