Duns Number:279456896
Device Description: E-SL5 surgery tip compatible EMSHYGITECHReference: HY-98214 Non-cutting spatula bent at 13 E-SL5 surgery tip compatible EMSHYGITECHReference: HY-98214 Non-cutting spatula bent at 135° allowing the sinus membrane to detach in depth inside the sinus and to clear anatomical structuresDiameter of the spatula: 4mm
Catalog Number
HY-98214
Brand Name
HYGITECH
Version/Model Number
HY-98214
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
-
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
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
e7cd6f4b-8701-4825-a22d-5f6baad5e974
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
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 | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |