Duns Number:192135242
Device Description: PMI Suture Guide Bariatric Length (12mm - 2 Holes) - Reusable
Catalog Number
PMISG12B2
Brand Name
PMI
Version/Model Number
PMISG12B2
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZX
Product Code Name
Guide, Surgical, Instrument
Public Device Record Key
1807dedb-fd2d-4736-bcd5-7ba178979ffd
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10812608020253
Quantity per Package
4
Contains DI Package
00812608020256
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 |