Duns Number:830016148
Device Description: 00118 270 DEGREES STEAM INDICATOR LG FORM 200/BX 20BX/CS 3M PK
Catalog Number
00118
Brand Name
Comply™
Version/Model Number
00118
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2017
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
217da66a-c8d5-49fd-87c0-5c9819bcc70b
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50707387469257
Quantity per Package
20
Contains DI Package
30707387469253
Package Discontinue Date
October 31, 2017
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |