H&H - Hydration healing for wounds1. absorbing exudate - TRONJEN TECHNOLOGY INC.

Duns Number:657246112

Device Description: Hydration healing for wounds1. absorbing exudate (reduce the number of dressing changes, t Hydration healing for wounds1. absorbing exudate (reduce the number of dressing changes, to avoid interference with wound healing)2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama)3. Perfect conformity (Conform to wound’s figure perfectly, patients feel comfortable in their daily movements)

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More Product Details

Catalog Number

HW2106

Brand Name

H&H

Version/Model Number

HW2106

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"

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

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Device Record Status

Public Device Record Key

21d12e80-63f4-4d81-90aa-84ce2b2ef265

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Additional Identifiers

Package DI Number

04719859641932

Quantity per Package

6

Contains DI Package

04719859641901

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TRONJEN TECHNOLOGY INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6