Duns Number:198227881
Device Description: CUFF TL REUSE 2 PC ADULT LONG 1TB LL
Catalog Number
3203XLSDSUNO
Brand Name
Welch Allyn, Inc.
Version/Model Number
901043
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
934323ee-e6e8-45bd-a474-281ceef9af5f
Public Version Date
June 29, 2022
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
00732094128666
Quantity per Package
5
Contains DI Package
00732094223187
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |