Catalog Number
-
Brand Name
ForceFlex
Version/Model Number
SS641
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PTX
Product Code Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
Public Device Record Key
e87d46f9-32b2-4cec-ba2e-1947b42adda0
Public Version Date
July 07, 2022
Public Version Number
1
DI Record Publish Date
June 29, 2022
Package DI Number
10810020085461
Quantity per Package
12
Contains DI Package
00810020085464
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 1369 |
U | Unclassified | 8 |