Catalog Number

1001-513BX

Brand Name

Scanlan® SUTURE BOOT™ Instrument Jaw Covers

Version/Model Number

1001-513BX

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

KDC

Product Code Name

Instrument, Surgical, Disposable

Public Device Record Key

d64c32d0-1130-41ec-b4cd-d3dd2c89d5f6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-