Duns Number:830016148
Device Description: 91111 HYDROGEL WOUND FILLER 25 GM 100/CV
Catalog Number
91111
Brand Name
3M™ Tegaderm™
Version/Model Number
91111
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
NAE
Product Code Name
Dressing, wound, hydrogel without drug and/or biologic
Public Device Record Key
35e834d8-60e5-4b20-b50e-59f6650ccf1c
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2018
Package DI Number
50707387564105
Quantity per Package
10
Contains DI Package
30707387564101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |