Duns Number:027680821
Device Description: This product is single use and intended to be used for blunt dissection of tissue
Catalog Number
-
Brand Name
Aspen® Endoscopic Kittner, Double Tip
Version/Model Number
KT-9105
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K913500,K913500
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
26f5fd41-ca90-4b26-b7a0-f0a9af8b8117
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 2021
Package DI Number
00840113213993
Quantity per Package
20
Contains DI Package
00840113214013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |