Duns Number:086911794
Device Description: A non-sterile device in the form of a long strip of stretchable, absorbent, woven material A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (gauze), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression.
Catalog Number
68999
Brand Name
Medi-First Roller Gauze 2" x 4 yards
Version/Model Number
68999
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
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
94fd10e8-57da-4c3d-8a98-6f34a26d0089
Public Version Date
July 29, 2019
Public Version Number
1
DI Record Publish Date
July 19, 2019
Package DI Number
50347682689990
Quantity per Package
200
Contains DI Package
00347682689995
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |