Duns Number:480797856
Device Description: The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required.
Catalog Number
-
Brand Name
Staysite Adhesive
Version/Model Number
SA-MAR
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
K071672,K101690,K151329,K041548,K151329,K101690,K071672,K041548,K041548,K071672,K101690,K151329
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
6cad696c-2261-416e-a80b-6ea996415130
Public Version Date
May 05, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
17640121880565
Quantity per Package
50
Contains DI Package
07640121880568
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |