Duns Number:080361159
Device Description: 8" X 10", 2MIL, CLEAR SINGLE POCKET, 2C, ZIP LOCK, 100/PK, 10/PKS, 1,000/CS
Catalog Number
-
Brand Name
COVANCE
Version/Model Number
COV810BIO
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
4d0e135f-8407-4319-a6f8-aa5defb7b28b
Public Version Date
August 23, 2022
Public Version Number
1
DI Record Publish Date
August 15, 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 |