Duns Number:198227881
Device Description: Welch Allyn 2.5 V Rechargeable Power Handle for Standard Laryngoscopes, CSA-US Certified, Welch Allyn 2.5 V Rechargeable Power Handle for Standard Laryngoscopes, CSA-US Certified, Charger Not Included; Medium Size; Nickel-Cadmium (#72000) Battery
Catalog Number
60710
Brand Name
Welch Allyn, Inc.
Version/Model Number
901087
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
K771900
Product Code
HLS
Product Code Name
Exophthalmometer
Public Device Record Key
25c8388f-964e-4996-8408-064bec48486b
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
January 16, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |