Specula Retractor Set - Lumbar Micro Disc Specula Retractor Set Consists - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Lumbar Micro Disc Specula Retractor Set Consists of the Following:1 x 7270-40 Lumbar Micro Lumbar Micro Disc Specula Retractor Set Consists of the Following:1 x 7270-40 Lumbar Micro Discectomy Specula Retractor 40mm, 1 x 7270-45 Lumbar Micro Discectomy Specula Retractor 45mm, 1 x 7270-50 Lumbar Micro Discectomy Specula Retractor 50mm, 1 x 7270-55 Lumbar Micro Discectomy Specula Retractor 55mm, 1 x 7270-60 Lumbar Micro Discectomy Specula Retractor 60mm, 1 x 7272-20 Micro Discectomy Specula Cross Retractor Frame Only, 1 x 7272-40 Micro Discectomy Blade 40mm Deep, 1 x 7272-45 Micro Discectomy Blade 45mm Deep, 1 x 7272-50 Micro Discectomy Blade 50mm Deep, 1 x 7272-55 Micro Discectomy Blade 55mm Deep, 1 x 7272-60 Micro Discectomy Blade 60mm Deep, 1 x 7272-65 Micro Discectomy Blade 65mm Deep & 1 x 7268-80 Blade Ejector

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More Product Details

Catalog Number

7271-00

Brand Name

Specula Retractor Set

Version/Model Number

7271-00

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

-

Product Code Details

Product Code

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

48508253-a889-4e29-b395-f7d001bdae52

Public Version Date

July 01, 2022

Public Version Number

1

DI Record Publish Date

June 23, 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