Duns Number:315768788
Device Description: ECONOLUX GZ 14,5tex ST 4X4 8P (12x50xP2
Catalog Number
-
Brand Name
ECONOLUX GZ 14,5tex ST 4X4 8P (12x50xP2
Version/Model Number
416104
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
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
0cc5d7d6-8f4a-44b2-8fd7-c8608bf2f2e4
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
40612553015707
Quantity per Package
12
Contains DI Package
20612553015703
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 99 |
U | Unclassified | 1 |