Duns Number:198227881
Device Description: CUFF TL DISP SOFT CHILD LONG 1TB MQ
Catalog Number
39108UNO
Brand Name
Welch Allyn, Inc.
Version/Model Number
901044
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2019
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
c14faa74-8a0f-4672-8478-ee384e65fe22
Public Version Date
November 04, 2019
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
00732094077742
Quantity per Package
20
Contains DI Package
00732094222951
Package Discontinue Date
November 01, 2019
Package Status
Not 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 |