Duns Number:447696675
Device Description: ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE L
Catalog Number
-
Brand Name
ESSENTIAL SURGICAL
Version/Model Number
30.D2302.00
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110724,K110724
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
23a62696-ab81-4b1c-96a2-825b140cdbc5
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 02, 2020
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |