Duns Number:315304071
Device Description: TEM GRASP. FORCEPS INSERT Ø 5MM angled downward and curved right, jaw length 28mm, for SL TEM GRASP. FORCEPS INSERT Ø 5MM angled downward and curved right, jaw length 28mm, for SL 450mm, single action, reusable
Catalog Number
8394621
Brand Name
ERAGON MODULAR
Version/Model Number
8394621
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCM
Product Code Name
ENDOSCOPE, RIGID
Public Device Record Key
bf3643b1-d8e8-4d65-8c18-98d05127b8be
Public Version Date
June 09, 2022
Public Version Number
6
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |