Duns Number:012430880
Device Description: Scissor Operating Germ Sh/Sh
Catalog Number
1004104
Brand Name
Henry Schein
Version/Model Number
1004104
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"
-
For Single-Use
-
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
LRW
Product Code Name
SCISSORS, GENERAL, SURGICAL
Public Device Record Key
2ee2a037-81c8-4178-9c1d-c57faef564bc
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
May 16, 2019
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 |