AESCULAP - HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML - B BRAUN SURGICAL SA

Duns Number:511268005

Device Description: HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

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More Product Details

Catalog Number

1050071

Brand Name

AESCULAP

Version/Model Number

1050071

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

MPN

Product Code Name

Tissue adhesive for the topical approximation of skin

Device Record Status

Public Device Record Key

e9c614a3-b4ea-47ef-bd1f-0ad5cb932a8f

Public Version Date

February 21, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

04046963656720

Quantity per Package

50

Contains DI Package

04046963835682

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"B BRAUN SURGICAL SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13