Duns Number:079471560
Device Description: DFX Tensile Tape 2.0 mm (UHMWPE) 18" Blue with a C-7 HALF Circle Taper Point Needle - 38.9 DFX Tensile Tape 2.0 mm (UHMWPE) 18" Blue with a C-7 HALF Circle Taper Point Needle - 38.9mm
Catalog Number
DFX0023S
Brand Name
DFX Tensile Tape
Version/Model Number
DFX0023S
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
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
K153746,K153746
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
ce4a7958-e36a-4897-b15d-42f230724c41
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
January 12, 2018
Package DI Number
00854629006451
Quantity per Package
12
Contains DI Package
00854629006444
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |