Duns Number:008162518
Device Description: SES Spare Reamer 40mm (Reamer Tube) for Hollow Reamer 3.5/4.0mm (gS 87.5435) for gS 98.300 SES Spare Reamer 40mm (Reamer Tube) for Hollow Reamer 3.5/4.0mm (gS 87.5435) for gS 98.3000
Catalog Number
gS 87.5535
Brand Name
gSource
Version/Model Number
gS 87.5535
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
HTO
Product Code Name
Reamer
Public Device Record Key
3b9f8d3d-1b57-4081-9659-361c9f15368f
Public Version Date
August 29, 2022
Public Version Number
3
DI Record Publish Date
March 03, 2020
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 | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |