Duns Number:071595540
Device Description: DETACHAPORT OBTURATOR AND SEAL SET, (10) 10MM X 100MM OBTURATOR, (10) 5MM, 10/12MM CONVERT DETACHAPORT OBTURATOR AND SEAL SET, (10) 10MM X 100MM OBTURATOR, (10) 5MM, 10/12MM CONVERTER
Catalog Number
1-7030
Brand Name
DETACHAPORT
Version/Model Number
1-7030
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 08, 2020
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
ececf5d0-288a-4c47-907f-27262d610434
Public Version Date
December 08, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405039010
Quantity per Package
10
Contains DI Package
30653405039017
Package Discontinue Date
December 08, 2020
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 |