APIS - Advanced Wound Care Product, 5x5cm - Sweetbio, Inc.

Duns Number:080210541

Device Description: Advanced Wound Care Product, 5x5cm

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More Product Details

Catalog Number

APIS-50x50-1

Brand Name

APIS

Version/Model Number

APIS-50x50-1

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

K182725

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

2394d906-f561-4105-8385-a684c6749cd7

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWEETBIO, INC." Characteristics
Device Class Device Class Description No of Devices
U Unclassified 3