Duns Number:012430880
Device Description: Lead Free Steam Indicator Tape 1"
Catalog Number
5701509
Brand Name
Henry Schein
Version/Model Number
5701509
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
K191741,K191741
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
c2c0f24c-3432-4806-a39c-6f126ef800a9
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
September 12, 2019
Package DI Number
10304040115456
Quantity per Package
36
Contains DI Package
00304040115459
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |