Duns Number:279456896
Device Description: Protect Plus kitHYGITECHReference: HY-0981The PROTECT PLUS kit is HYGITECH's most comprehe Protect Plus kitHYGITECHReference: HY-0981The PROTECT PLUS kit is HYGITECH's most comprehensive kit, offering a variety of products to ensure the full protection of the surgery, including drapes and clothing for the surgeon, assistant and patient. Each kit contains 58 items.4 Polyethylene gloves2 Tie-on masks2 Surgical hats3 Bouffant caps1 Patient gown with cotton cuffs2 Surgical gowns with cotton cuffs1 Pair of overshoes for patient2 Pairs of non-slip overshoes2 Sterile brushes with nail cleaner4 Paper hand-towels2 Saliva ejectors3 Adhesive protective covers for control panel1 Protective PVC X-ray cover2 Adhesive films (2" x 31.5" / 5x80cm)1 Chair cover with 6 ties4 Protective sleeves for tubing (3.5" x 47" / 8 x 120cm) 3 Non-latex elastic bands2 Elastic cap handle covers1 Tube support with adhesive1 Surgical drape (59" x 59" / 150x150cm) with adhesive1 Absorbent drape (59" x 59" / 150x150cm) with adhesive2 Surgical drapes (39" x 39" / 100x100 cm) with adhesive1 Surgical drape with aperture and adhesive (27.5" x 31.5" / 70x80cm)1 Surgical drape with aperture (27.5" x 31.5" / 70x80cm)2 Ice bags1 Plastic bag (20" x 31.5" / 50x80cm)1 Wrapping paper
Catalog Number
HY-0981
Brand Name
HYGITECH
Version/Model Number
HY-0981
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
dea799ad-1d6b-4c71-8608-d861060c7650
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
03615140005166
Quantity per Package
5
Contains DI Package
03615140005159
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 |