Duns Number:344007369
Device Description: The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap)
Catalog Number
400.05
Brand Name
remOVE FBR Set
Version/Model Number
12
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"
Yes
For Single-Use
Yes
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
KOA
Product Code Name
Surgical Instruments, G-U, Manual (And Accessories)
Public Device Record Key
ad673a45-404d-428a-9233-0e95e3faa4ff
Public Version Date
October 31, 2019
Public Version Number
3
DI Record Publish Date
October 02, 2018
Package DI Number
04260206310778
Quantity per Package
2
Contains DI Package
04260206310785
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
folding box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |