Duns Number:382174019
Device Description: Polyester Tape size 3.2mm x 76.2cm (1/8 in x 30 in) are commercially available only in mul Polyester Tape size 3.2mm x 76.2cm (1/8 in x 30 in) are commercially available only in multipack configuration (1 pair per pouch/5 pouches per box) with the catalog number M002000194031.
Catalog Number
-
Brand Name
POLYESTER TAPE
Version/Model Number
Size 3.2mm x 76.2cm (1/8 in x 30 in)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
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
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
87afd06a-b42a-4053-8164-f60e5ba52966
Public Version Date
September 10, 2019
Public Version Number
3
DI Record Publish Date
May 16, 2017
Package DI Number
00384401513209
Quantity per Package
5
Contains DI Package
00384401513117
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |