Duns Number:198227881
Device Description: 590 LARGE DLV ASSEMBLY
Catalog Number
411251
Brand Name
Welch Allyn, Inc.
Version/Model Number
901071
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
K120743,K120743,K120743,K120743
Product Code
HIB
Product Code Name
Speculum, vaginal, nonmetal
Public Device Record Key
24501dd4-6031-4dda-9fbc-9a924bcd9eaf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 05, 2017
Package DI Number
00732094239140
Quantity per Package
14
Contains DI Package
00732094239157
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 |