Duns Number:007941230
Device Description: Dressing Wound Transparent Film 4 Inch X 4.75 Inch Sterile Not Made With Natural Rubber La Dressing Wound Transparent Film 4 Inch X 4.75 Inch Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
TD1004
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
KMK
Product Code Name
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Public Device Record Key
9b49c931-b6d1-4081-9497-693f36094174
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 21, 2020
Package DI Number
30885632127063
Quantity per Package
50
Contains DI Package
10885632127069
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |