Duns Number:015272206
Device Description: Tebbetts-type nasal septum scissors, 7'', angled TC blades, micro serrated lower blade, bl Tebbetts-type nasal septum scissors, 7'', angled TC blades, micro serrated lower blade, blunt tips, gold ring handle
Catalog Number
80-340
Brand Name
Ambler Surgical
Version/Model Number
Tebbetts-type nasal septum scissors
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
KBD
Product Code Name
SCISSORS, NASAL
Public Device Record Key
2f1cf02e-af7f-401d-b6c2-7edad6e6ecbd
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 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 | 14984 |
2 | A medical device with a moderate to high risk that requires special controls. | 3118 |