Duns Number:053435368
Device Description: LC1 GREENSTEIN GRIPPER- Clamp designed to hold instruments, trocars, and scopes during lap LC1 GREENSTEIN GRIPPER- Clamp designed to hold instruments, trocars, and scopes during laparoscopic surgery. Holds diameters from 3mm-12mm
Catalog Number
LC10GG
Brand Name
Greenstein Gripper
Version/Model Number
LC1 Greenstein Gripper
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
GAD
Product Code Name
Retractor
Public Device Record Key
896a85e7-410d-49a0-a863-0b39f8ccff7b
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 12, 2022
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 | 182 |