Duns Number:192135242
Device Description: PMI Disposable Bariatric Site Closure Kit (3 Piece) Includes: (1) PMI Disposable Bariatric PMI Disposable Bariatric Site Closure Kit (3 Piece) Includes: (1) PMI Disposable Bariatric Suture Grasper (1) PMI Disposable 10/12mm Suture Guide (1) PMI Disposable 15 mm 4-hole Bariatric Suture Guide
Catalog Number
-
Brand Name
PMI
Version/Model Number
PMITCSGXLKT
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
72f9ad4b-6ba6-408c-9665-356317fd5ade
Public Version Date
March 23, 2020
Public Version Number
1
DI Record Publish Date
March 13, 2020
Package DI Number
00812608022083
Quantity per Package
10
Contains DI Package
00812608022076
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |