Bayonet Suction Retractor - Bayonet Suction Retractor 7mm tip 12 cm working - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Bayonet Suction Retractor 7mm tip 12 cm working length

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More Product Details

Catalog Number

-

Brand Name

Bayonet Suction Retractor

Version/Model Number

7220-10

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K875290,K875290

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

fcf26b5d-6821-4c98-937f-0f1972c884eb

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOROS U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2597
2 A medical device with a moderate to high risk that requires special controls. 416