Duns Number:481542926
Device Description: FRC-21 RB-8 TC Forceps, 21 cm long, round handle 8 mm, curved, tip 1.0 mm, Plateau, TC (CR FRC-21 RB-8 TC Forceps, 21 cm long, round handle 8 mm, curved, tip 1.0 mm, Plateau, TC (CRYS&TAL)
Catalog Number
00808
Brand Name
NA
Version/Model Number
FRC-21 RB-8 TC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
ac7d8756-1189-4cec-b53d-f39308247692
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 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 | 306 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |