Duns Number:791014871
Device Description: Sterilization Pouches, 3.5" x 10", NS
Catalog Number
27304-BK
Brand Name
Dukal
Version/Model Number
27304-BK
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162258,K162258
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
fd56a235-df22-4232-8b27-4dd2fd6a5886
Public Version Date
May 23, 2022
Public Version Number
2
DI Record Publish Date
March 30, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |