Duns Number:187502109
Device Description: HD Camera Head, C-Mount, with 3 m Cable
Catalog Number
1188210105
Brand Name
1188
Version/Model Number
1188210105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 04, 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
K142603
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
0a9542cc-1293-4ff3-b769-48c06fc90643
Public Version Date
March 04, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |