Duns Number:198227881
Device Description: Welch Allyn Pocket Junior 2.5 V Halogen AA Power Handle; Instrument Head Not Included, Bat Welch Allyn Pocket Junior 2.5 V Halogen AA Power Handle; Instrument Head Not Included, Batteries Not Included
Catalog Number
72741
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
-
Product Code
HLS
Product Code Name
Exophthalmometer
Public Device Record Key
9236e3c5-23df-4e03-bd21-f02955a2386f
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
December 08, 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 |