Duns Number:008124539
Device Description: Krinkle Gauze Roll, Sterile, 4.5"x4.1yd., 6-ply
Catalog Number
-
Brand Name
Krinkle Gauze Roll, Sterile
Version/Model Number
3161
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)
Yes
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
fb254efe-ac92-44b9-bbd9-f6c2490bbad3
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
June 21, 2021
Package DI Number
00616784316130
Quantity per Package
100
Contains DI Package
00616784316116
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |