Duns Number:187502109
Device Description: Operating Laparoscope, Non-Autoclavable, 90 ¿¿Eyepiece, 5.0 mm Working Channel, 10 mm Oute Operating Laparoscope, Non-Autoclavable, 90 ¿¿Eyepiece, 5.0 mm Working Channel, 10 mm Outer Diameter x 0 ¿ View Direction, 27 cm Working Length
Catalog Number
0331-010-090
Brand Name
NA
Version/Model Number
0331010090
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
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
973793da-b172-4456-8839-608edb66d000
Public Version Date
November 23, 2021
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |