Duns Number:012430880
Device Description: Sponge Premium Non Sterile 4x4 8Ply
Catalog Number
5702646
Brand Name
Henry Schein
Version/Model Number
5702646
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
-
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
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
255fb089-27af-460c-a32e-c689931e1cad
Public Version Date
May 18, 2021
Public Version Number
1
DI Record Publish Date
May 10, 2021
Package DI Number
20304040153660
Quantity per Package
20
Contains DI Package
10304040153663
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 |