Duns Number:279456896
Device Description: Effective and comfortable waterproof protection for the patient White cover with elastic l Effective and comfortable waterproof protection for the patient White cover with elastic lining, easy to fix on the dental chair keeping the handle uncoveredFavours the impression of cleanness and care for hygiene of the surgeryFits any kind of dental chair, 24cm diameter More infoResistant, does not tear: polypropylene (12g/m² ), coated with polyethylene (18g/m² )Easy to stock: boxes of 50 pieces eachAllows to limit the use of disinfectants and makes the dental chair last longer Dispenser box
Catalog Number
HY-60060
Brand Name
HYGITECH
Version/Model Number
HY-60060
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGN
Product Code Name
Scissors, Surgical Tissue, Dental
Public Device Record Key
6cbb427f-a5c5-45b2-812b-c6f81d3a1123
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
December 14, 2020
Package DI Number
03615140003858
Quantity per Package
10
Contains DI Package
03615140003841
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |