Duns Number:187502109
Device Description: HD Camera Head, C-Mount with 3 m Cable
Catalog Number
1188-510-105
Brand Name
1188
Version/Model Number
1188510105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 26, 2018
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
161d2c0d-0340-42ef-a056-c06a96788686
Public Version Date
September 26, 2018
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 |