Duns Number:081277700
Device Description: Explorer, 23, Single End, GripLite® S6
Catalog Number
80-5300
Brand Name
Integra® Miltex®
Version/Model Number
80-5300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2022
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
-
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
EKB
Product Code Name
EXPLORER, OPERATIVE
Public Device Record Key
9053544b-5024-4ea5-b164-31f7843eb8ad
Public Version Date
July 20, 2022
Public Version Number
3
DI Record Publish Date
October 23, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |