Duns Number:080061451
Device Description: Material 43gsm A/S SMMS Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 50 Ster Material 43gsm A/S SMMS Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 50 Sterile Pouch - Case
Catalog Number
-
Brand Name
HEPRO.US Reinforced Surgical Gown Case 43gsm
Version/Model Number
CT - Reinforced Surgical Gown 43gsm SMMS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
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
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
a6d8d299-bded-4eab-93dd-39dd798e7c85
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
June 21, 2017
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |