Duns Number:121788819
Device Description: 1 PLY WRAPPER 36X36 SERGE
Catalog Number
-
Brand Name
Encompass
Version/Model Number
26188-036
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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
1122ed60-00f0-4f23-86e1-dea6ba7bec89
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
50609953901201
Quantity per Package
36
Contains DI Package
00609953901206
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 112 |