Duns Number:315018218
Device Description: BIRKETT SUSI Hemostatic Forceps, curved, 7 1/4", (185 mm), sterile, disposable, pack of 20 BIRKETT SUSI Hemostatic Forceps, curved, 7 1/4", (185 mm), sterile, disposable, pack of 20 pcs, single packed
Catalog Number
BH197SU
Brand Name
SUSI
Version/Model Number
BH197SU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 12, 2022
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
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
GEN
Product Code Name
FORCEPS, GENERAL & PLASTIC SURGERY
Public Device Record Key
674fc429-e6f4-4326-99b1-4b58f4c74d4d
Public Version Date
April 15, 2022
Public Version Number
2
DI Record Publish Date
April 24, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |