Duns Number:109903521
Device Description: SEAL CAP OPERATIVE LAPAROSCOPE
Catalog Number
7205561
Brand Name
Hysteroscope Seal Caps
Version/Model Number
7205561
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
-
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
K980604,K980604
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
f79ae8cd-a964-4633-88bb-6c537f6642db
Public Version Date
January 31, 2020
Public Version Number
4
DI Record Publish Date
October 05, 2015
Package DI Number
23596010465966
Quantity per Package
5
Contains DI Package
03596010465962
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |