Duns Number:828660345
Device Description: Reusable Graham Decompression Scissors, curved right, for cutting soft tissue.
Catalog Number
GM-DS-LR
Brand Name
Graham Decompression Scissors, Curved Right
Version/Model Number
11-470-11-CR (14cm/5.5")
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HRR
Product Code Name
Scissors, Orthopedic, Surgical
Public Device Record Key
9408809b-ca49-4844-b00b-cc5b17102896
Public Version Date
September 23, 2022
Public Version Number
5
DI Record Publish Date
January 27, 2017
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 89 |