Duns Number:071595540
Device Description: DETACHAPORT OBTURATOR AND SEAL SET, (10) 12MM X 100MM OBTURATOR, (20) 5MM, 10/12MM CONVERT DETACHAPORT OBTURATOR AND SEAL SET, (10) 12MM X 100MM OBTURATOR, (20) 5MM, 10/12MM CONVERTER
Catalog Number
1-7033
Brand Name
DETACHAPORT
Version/Model Number
1-7033
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2016
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
K952977,K952977,K952977,K952977
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
1d3e9b4e-feb5-4ef8-b389-64517c45cd54
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405039041
Quantity per Package
10
Contains DI Package
30653405039048
Package Discontinue Date
December 31, 2016
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |