Duns Number:004382282
Device Description: FORCEPS MICRO; 6"(15CM), 8MM ROUND HANDLE, COUNTERWEIGHT WITH GUIDE PIN 2MM, PLATFORM 6X 0 FORCEPS MICRO; 6"(15CM), 8MM ROUND HANDLE, COUNTERWEIGHT WITH GUIDE PIN 2MM, PLATFORM 6X 0.3MM, CVD
Catalog Number
B3FRC-15 RM-8.2
Brand Name
N/A
Version/Model Number
B3FRC-15 RM-8.2
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
GEN
Product Code Name
FORCEPS, GENERAL & PLASTIC SURGERY
Public Device Record Key
e835d2e9-927a-430d-8916-9ece44a5c42e
Public Version Date
September 29, 2022
Public Version Number
1
DI Record Publish Date
September 21, 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 | 5533 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 240 |