Duns Number:081277700
Device Description: Wormald Anterior Skull Base and Pituitary Instrument Tray, 52.7cm L x 25cm W x 12cm D
Catalog Number
MCEN143
Brand Name
Integra®
Version/Model Number
MCEN143
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
-
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
MMO
Product Code Name
TRAY, SURGICAL, ENT
Public Device Record Key
30062463-93d4-40cb-9fd5-ad7d65ef5d0a
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
October 26, 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 |