Duns Number:187502109
Device Description: Extension Cable for the 1588 AIM Camera System
Catalog Number
1588-000-080
Brand Name
1588
Version/Model Number
1588000080
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
K132785
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
36e5e419-a2f5-42c5-b276-613f9dab83d4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 12, 2017
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 |