Duns Number:058614483
Device Description: Braided Polyester,Pre-Cut,2x White Strands
Catalog Number
-
Brand Name
Polyester Tape
Version/Model Number
88868618-00
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
-
Product Code
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
5c349449-cc06-4991-8fee-d636ae5dc690
Public Version Date
July 12, 2021
Public Version Number
5
DI Record Publish Date
August 31, 2015
Package DI Number
20884521104447
Quantity per Package
36
Contains DI Package
10884521104440
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |