Duns Number:021628771
Device Description: OB/GYN FILTER PACK, FOR SMOKE EVACUATOR. Medical Device. The three pack is the FIL1-3.
Catalog Number
FIL1-1
Brand Name
Geiger Smoke Evacuator Filter
Version/Model Number
FIL1-1
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
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
69818e7e-c2d4-45ce-a873-947e9844dbcd
Public Version Date
August 10, 2018
Public Version Number
1
DI Record Publish Date
July 10, 2018
Package DI Number
10609960000692
Quantity per Package
3
Contains DI Package
00609960000695
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 90 |