Duns Number:968344643
Device Description: 7mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Po 7mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder Free, Textured Finger Tips, Steel Blue, Size 3X-Large
Catalog Number
-
Brand Name
Intercept
Version/Model Number
1LICNG-3XL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2020
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091147,K091147,K091147
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
0d524859-e18e-43d1-8942-3a6371e32e77
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
August 01, 2020
Package DI Number
10850018123812
Quantity per Package
10
Contains DI Package
00850018123815
Package Discontinue Date
August 01, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |