Duns Number:025460908
Device Description: GOWN, NONREINFORCED, SPUNLACE, L
Catalog Number
16835NS
Brand Name
Medline
Version/Model Number
16835NS
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
FME
Product Code Name
GOWN, EXAMINATION
Public Device Record Key
69cc265b-4a39-4bb2-a766-84c21b5d8570
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
40080196001614
Quantity per Package
60
Contains DI Package
10080196001613
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |