Catalog Number

88868631-12

Brand Name

Bolsters

Version/Model Number

88868631-12

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

KGS

Product Code Name

RETENTION DEVICE, SUTURE

Public Device Record Key

3257657d-ca78-4816-b373-81ac94a3108e

Public Version Date

September 19, 2018

Public Version Number

1

DI Record Publish Date

August 19, 2018

Package DI Number

20884521113340

Quantity per Package

12

Contains DI Package

10884521113343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE