Duns Number:830016148
Device Description: 3M™ ESPE™ Lead Free Autoclave Steam Indicator Tape, 24mm, 1322C
Catalog Number
1322C
Brand Name
ESPE™
Version/Model Number
1322C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 13, 2022
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)
Yes
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
9df0a9b4-7e47-4dcb-895a-c465ac021946
Public Version Date
October 14, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
50605861059133
Quantity per Package
10
Contains DI Package
30605861059139
Package Discontinue Date
October 13, 2022
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 |