Duns Number:080061451
Device Description: 1PC Mayo Stand, 2Pc OP-Tape, 2Pc Hand Towel,2Pc Side Drape, 1Pc Top Drape, 1Pc Foot Drape, 1PC Mayo Stand, 2Pc OP-Tape, 2Pc Hand Towel,2Pc Side Drape, 1Pc Top Drape, 1Pc Foot Drape, 2 Pc Reinforced table Cover, 1Pc Wrapper 10 Pouches per Case
Catalog Number
-
Brand Name
HEPRO. US General Pack - 10 Pouches-Case
Version/Model Number
CT - General 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
a2c12a4d-85e7-471e-a650-e8755555043f
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 |