Catalog Number

GIS-2-S

Brand Name

PediaBloc Endoscopy Bite Block

Version/Model Number

GIS-2

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K931044,K931044,K931044

Product Code

MNK

Product Code Name

Endoscopic Bite Block

Public Device Record Key

59479bcc-a547-4814-9821-8a0a1387df76

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Package DI Number

10893029002530

Quantity per Package

100

Contains DI Package

00893029002533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master