Duns Number:079641356
Device Description: Rapidclean® Grasper, Traumatic, Insert, Handle, & Lumen (99-11302L & 99-00000L), Optilengt Rapidclean® Grasper, Traumatic, Insert, Handle, & Lumen (99-11302L & 99-00000L), Optilength, 2x3 Teeth, 5 mm
Catalog Number
99-21302L
Brand Name
Symmetry Surgical®
Version/Model Number
99-21302L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
K925079
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
39e337c8-2387-450b-b11c-e20f8ee34325
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
September 25, 2018
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 | 7981 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3309 |