Duns Number:486911852
Device Description: Gastric Band Sutureless Port and Applier
Catalog Number
RLZPT2
Brand Name
NA
Version/Model Number
RLZPT2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 13, 2020
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
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
LTI
Product Code Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Public Device Record Key
f11c5867-46d2-4010-871c-a6b451332756
Public Version Date
April 14, 2020
Public Version Number
3
DI Record Publish Date
September 17, 2014
Package DI Number
30705036004015
Quantity per Package
16
Contains DI Package
20705036004018
Package Discontinue Date
April 13, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 2 |