Duns Number:279456896
Device Description: Paro kitHYGITECHReference: HY-08811The PARO kit is specifically designed for preventing cr Paro kitHYGITECHReference: HY-08811The PARO kit is specifically designed for preventing cross-infection during your short routine procedures: tooth extraction, parodontology. The kit contains 12 items.1 Surgical hat1 Bouffant cap1 Tie-on mask1 Pair of overshoes1 Surgical brush with nail cleaner2 Paper hand-towels1 Surgical gown with cotton cuffs1 Surgical drape with aperture and adhesive (29.5"x 35.5"/ 75x90cm)1 U-Shaped surgical drape with adhesive (29.5"x 35.5"/ 75x90cm)1 Wrapping paper
Catalog Number
HY-08811
Brand Name
HYGITECH
Version/Model Number
HY-08811
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
ae71f157-6468-4c33-a1df-ca27664ea35a
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
03615140005289
Quantity per Package
5
Contains DI Package
03615140005272
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 | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |