Duns Number:015272206
Device Description: Myringotomy sickle knife, straight, full handle knife, flat stock, packaged individually, Myringotomy sickle knife, straight, full handle knife, flat stock, packaged individually, sterile, disposable, box of 6
Catalog Number
7300H
Brand Name
Ambler Surgical
Version/Model Number
Myringotomy sickle knife
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
Yes
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
JYO
Product Code Name
KNIFE, EAR
Public Device Record Key
77b8ee19-a60b-44f7-bc26-b0e8b7b94343
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
January 04, 2021
Package DI Number
00190660200381
Quantity per Package
6
Contains DI Package
10190660200388
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |