Duns Number:200564891
Device Description: Gazetex 1.5 in X 2 in diameter "krinkle" type prep sponge. Large with twisted knot. Bulk p Gazetex 1.5 in X 2 in diameter "krinkle" type prep sponge. Large with twisted knot. Bulk packed 400/case
Catalog Number
DUP4500L
Brand Name
Gazetex®
Version/Model Number
4500L
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
829b4df0-957e-431d-b70e-a578d4a73970
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
October 23, 2018
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |