Health-Tec/DHP Sponges - Health-Tec/DHP Non-Woven Sponges 2" x 2" 4-Ply - Dental Health Products Inc

Duns Number:623191194

Device Description: Health-Tec/DHP Non-Woven Sponges 2" x 2" 4-Ply Non-Sterile 200/sleeve

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More Product Details

Catalog Number

250-5002S2

Brand Name

Health-Tec/DHP Sponges

Version/Model Number

250-5002S2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Device Record Status

Public Device Record Key

2ae1c304-7dfb-4f4d-8b9a-588ead76a70a

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL HEALTH PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 464
2 A medical device with a moderate to high risk that requires special controls. 78