Duns Number:187502109
Device Description: [Two Spike Irrigator Set, Non-pyrogenic fluid path, Do not use if package is damaged]
Catalog Number
350-195-000
Brand Name
NA
Version/Model Number
0350195000
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
K000493,K000493
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
f8117d73-56a5-4ddf-ae15-dbcd951f4743
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
37613327061667
Quantity per Package
10
Contains DI Package
07613327061666
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |