Duns Number:080361159
Device Description: 7.25 X 29", 4MIL, SEACOLE E-Z SPREAD ICE MELT, LDPE CLEAR BAG W/CUSTOM ANGLE SEAL, 100/PK, 7.25 X 29", 4MIL, SEACOLE E-Z SPREAD ICE MELT, LDPE CLEAR BAG W/CUSTOM ANGLE SEAL, 100/PK, 10/PKS, 1000/CS
Catalog Number
-
Brand Name
INTERNATIONAL PLASTICS INC.
Version/Model Number
C-SESP06-01
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"
-
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
NNK
Product Code Name
Container, Specimen Mailer And Storage, Non-Sterile
Public Device Record Key
07425079-31e2-4a6c-999b-6f0024a272c9
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |