Duns Number:187129135
Device Description: (1) SPECIMEN CONTAINMENT BAG, 14CM DIAMETER, (1) SMALL GUARD, (1) MEDIUM GUARD, (1) RETRAC (1) SPECIMEN CONTAINMENT BAG, 14CM DIAMETER, (1) SMALL GUARD, (1) MEDIUM GUARD, (1) RETRACTOR
Catalog Number
-
Brand Name
Alexis® Contained Extraction System
Version/Model Number
GTB14
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
c01cf95d-bb79-4524-94d8-d7d8eff87e92
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
10607915141797
Quantity per Package
3
Contains DI Package
00607915134273
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |