Duns Number:616182895
Catalog Number
ICM-000-0438
Brand Name
Attacha Vac
Version/Model Number
2120-09EC
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"
Yes
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
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
2da121da-4b8a-459c-b5c5-9d8eb90acf71
Public Version Date
April 08, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
00817688021247
Quantity per Package
25
Contains DI Package
00817688021230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 180 |