Duns Number:961027315
Device Description: AMBITEX GLV EXAM NON-STERILE STRETCH VINYL V221 CREAM POWDER-FREE EXTRA LARGE SMOOTH STAND AMBITEX GLV EXAM NON-STERILE STRETCH VINYL V221 CREAM POWDER-FREE EXTRA LARGE SMOOTH STANDARD LENGTH 10/100
Catalog Number
VXL221
Brand Name
AMBITEX
Version/Model Number
VXL221
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYZ
Product Code Name
Vinyl patient examination glove
Public Device Record Key
548676cf-e0ef-40f6-968e-a8ed310483f0
Public Version Date
May 18, 2020
Public Version Number
2
DI Record Publish Date
April 04, 2019
Package DI Number
10699320702557
Quantity per Package
10
Contains DI Package
00699320702550
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |