Duns Number:049290364
Device Description: 10MM, 36CM, DEBAKEY GRASPER, 60MM JAW ROTATABLE, ONE PIECE W/ FLUSHPORT NON-INSULATED STAI 10MM, 36CM, DEBAKEY GRASPER, 60MM JAW ROTATABLE, ONE PIECE W/ FLUSHPORT NON-INSULATED STAINLESS STEEL W/ RATCHET
Catalog Number
52103-23B
Brand Name
ELMED
Version/Model Number
52103-23B
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
822e2c13-2d4e-45bf-a847-79153f609045
Public Version Date
June 09, 2022
Public Version Number
1
DI Record Publish Date
June 01, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4068 |