Catalog Number

B68E

Brand Name

HAVEL'S

Version/Model Number

C7 3/0 BBS 18"/45 CM ON CARD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

adeeac5a-1cca-49d1-9651-c17c8c83964c

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 16, 2016

Package DI Number

B070B68E1

Quantity per Package

12

Contains DI Package

B070B68E0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-