Duns Number:002144145
Device Description: Surgiflo Endoscopic Appicator
Catalog Number
MS1995
Brand Name
ETHICON
Version/Model Number
MS1995
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
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
K051732,K051732
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
1948e756-563f-475b-a030-55c86b2fd12a
Public Version Date
November 25, 2020
Public Version Number
7
DI Record Publish Date
September 23, 2015
Package DI Number
20705031131955
Quantity per Package
6
Contains DI Package
10705031131958
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |