Duns Number:013112308
Device Description: SURGEON'S GOWN, LARGE, KNITTED CUFF WITH 2 PIECE HAND TOWEL & WRAP - 1 EA/POUCH.
Catalog Number
SUSSG002
Brand Name
Rospital Productos Medicos
Version/Model Number
SUSSG002
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173847,K173847
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
8b15d677-1cbb-4817-bbad-db28ae9fbcec
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
July 06, 2020
Package DI Number
10812460028107
Quantity per Package
50
Contains DI Package
00812460028100
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |