HK Sterile Super Absorbent Pads Medium - HK Sterile Super Absorbent Pads Medium - HK SURGICAL INC.

Duns Number:106885259

Device Description: HK Sterile Super Absorbent Pads Medium

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More Product Details

Catalog Number

SPD-M

Brand Name

HK Sterile Super Absorbent Pads Medium

Version/Model Number

SPD-M

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

FRL

Product Code Name

Fiber, Medical, Absorbent

Device Record Status

Public Device Record Key

c7e87858-7e3d-44a8-ab5b-a7ce42e03590

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

December 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HK SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 12