Duns Number:317654283
Device Description: 1206-19150
Catalog Number
1206-19150
Brand Name
CUTTING INTRODUCER
Version/Model Number
1206-19150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 25, 2024
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
49c1c6d7-4a01-4327-82ec-4d55ca4a7f11
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
April 02, 2021
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |