Duns Number:830997032
Device Description: 36" x 36" Sterilization Wrap
Catalog Number
-
Brand Name
KIMGUARD™ KC600 Sterilization Wrap
Version/Model Number
68636
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)
-
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
c6342bdf-b8bb-4444-81aa-64e3e0ccc4cb
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
10036000686361
Quantity per Package
2
Contains DI Package
00036000686364
Package Discontinue Date
-
Package Status
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 |