Catalog Number

1012A

Brand Name

Iotec

Version/Model Number

1012A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2016

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

K944509,K944509

Product Code

HIF

Product Code Name

INSUFFLATOR, LAPAROSCOPIC

Public Device Record Key

f7911f22-9827-4033-9c3f-4c4b41b8d5d6

Public Version Date

February 05, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884521080796

Quantity per Package

12

Contains DI Package

10884521080799

Package Discontinue Date

September 24, 2016

Package Status

Not in Commercial Distribution

Package Type

CASE