Duns Number:080061451
Device Description: 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with Elastic 160x 240cm - 30 Non-Sterile Pouch Copy
Catalog Number
-
Brand Name
HEPRO.US Welcome Pack - Case
Version/Model Number
CT - Welcome Pack
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
ERY
Product Code Name
Drape, Surgical, Ent
Public Device Record Key
d685dcb4-be88-4f8b-bef2-41622ce06237
Public Version Date
March 29, 2018
Public Version Number
2
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 |