Duns Number:040729840
Device Description: Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 X 4 Millimeters Cup Curved Right Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 X 4 Millimeters Cup Curved Right Quantum
Catalog Number
-
Brand Name
Laryngoscopy Forceps
Version/Model Number
1301-288Q
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"
Yes
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
KAE
Product Code Name
FORCEPS, ENT
Public Device Record Key
84d6c313-312d-4fe1-83b7-89a9c9dbdc42
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 2021
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |