Duns Number:131084188
Device Description: CHITOSAM 100, 3IN X 6FT
Catalog Number
-
Brand Name
Chito-SAM™ 100
Version/Model Number
CT100-C-EN
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
K133121,K133121
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
5e8984f0-c6d4-48ff-8d91-9bc629bf0eeb
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
10822045000008
Quantity per Package
15
Contains DI Package
00822045000001
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 | 58 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |
U | Unclassified | 3 |