Catalog Number

055921

Brand Name

Dalbo®-PLUS / Dalbo®-Classic / Dalbo®-B

Version/Model Number

055921

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EJX

Product Code Name

Anchor, Preformed

Public Device Record Key

838ba023-d982-4ea7-83ff-730fb3dd9e67

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-