Duns Number:012430880
Device Description: SCHEIN NON LATEX DAM 6X6 PURPLE HEAVY PLAIN (0.30MM)
Catalog Number
5701622
Brand Name
Henry Schein
Version/Model Number
5701622
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 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"
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
-
Product Code
EIE
Product Code Name
DAM, RUBBER
Public Device Record Key
9acc6d7f-6c65-4978-aa00-1698ed8386c1
Public Version Date
April 11, 2022
Public Version Number
1
DI Record Publish Date
April 01, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |