Duns Number:071595540
Device Description: MICROLAP TROCAR SEAL, SINGLE USE (1/STERILE)
Catalog Number
C-LIL-SEAL-1
Brand Name
MICROLAP
Version/Model Number
C-LIL-SEAL-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 2021
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
K140101,K140101,K140101
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
f785a5c6-592c-47eb-8b25-11558975e4a8
Public Version Date
July 27, 2021
Public Version Number
4
DI Record Publish Date
April 18, 2017
Package DI Number
20653405006142
Quantity per Package
25
Contains DI Package
10653405006145
Package Discontinue Date
July 27, 2021
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 |