Duns Number:428755441
Device Description: This Personal Protective Equipment (P.P.E.) is designed and manufactured exclusively to pr This Personal Protective Equipment (P.P.E.) is designed and manufactured exclusively to protect the user against minor or easily reversible impacts resulting from the use of mechanical equipment and/or cleaning products.This P.P.E. also protects against: risks due to contact with hot components having a temperature not exceeding 50°C (normal environmental conditions when working); minor impacts. It is not suitable to protect against the following risks: chemical, heat, fire, cold, poor visibility and electric shock.Monoart bandana with adjustable ties that can fit all sizes. Thanks to the top-quality, colour-fast cotton used,it is autoclavable at 121°C. Single pack, carton of 10 pieces of the same colour. Colour: light blue
Catalog Number
262003
Brand Name
Monoart
Version/Model Number
MONOART BANDANA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYF
Product Code Name
Cap, Surgical
Public Device Record Key
e8e3f520-6cff-489b-8444-f2b1d2a9ab92
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
December 17, 2019
Package DI Number
E3072620031
Quantity per Package
10
Contains DI Package
E3072620030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 126 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |