Duns Number:649827193
Device Description: The kit contains: 1 X Ring units box (6 Ring units/box), 3 X 10mm Clippers set box (2 Clip The kit contains: 1 X Ring units box (6 Ring units/box), 3 X 10mm Clippers set box (2 Clippers set/box)
Catalog Number
-
Brand Name
AutoLap Sterile Components Kit Package- Ring, 10mm
Version/Model Number
ASS02130US
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
K131375,K152848
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
43033284-ca1b-47c2-a8ec-35a033fa7ed3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |