Duns Number:012430880
Device Description: Suture Removal Kit
Catalog Number
5700619
Brand Name
Henry Schein
Version/Model Number
5700619
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MCZ
Product Code Name
Suture removal kit
Public Device Record Key
b8c5a4b3-a8b0-4d6d-a396-c87d65aae5ec
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 13, 2017
Package DI Number
10304040057091
Quantity per Package
50
Contains DI Package
00304040057094
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 |