Duns Number:007198742
Catalog Number
-
Brand Name
PLEATMAN SAC, Disposable Tissue Removal System
Version/Model Number
004942-903
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 22, 2017
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"
-
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
K923945,K923945
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
562f8161-5f43-4e1a-88d1-0137c363115b
Public Version Date
October 06, 2022
Public Version Number
4
DI Record Publish Date
October 07, 2016
Package DI Number
00821925009431
Quantity per Package
10
Contains DI Package
00821925041660
Package Discontinue Date
March 22, 2017
Package Status
Not 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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |