Duns Number:279456896
Device Description: Implanwear kitHYGITECHReference: HY-08511The IMPLANWEAR kit is intended for heavy implant Implanwear kitHYGITECHReference: HY-08511The IMPLANWEAR kit is intended for heavy implant surgeries involving a surgeon, an assistant and the patient. It contains all clothing items needed to protect 3 people. The kit is composed of 28 items.2 Surgical hats3 Bouffant caps1 Pair of patient overshoes2 Pairs of non-slip overshoes3 Tie-on masks2 Surgical brushes with nail cleaner6 Paper hand-towels1 Assistant gown with cotton cuffs1 Patient gown with cotton cuffs1 Surgical gown with cotton cuffs1 Wrapping paper
Catalog Number
HY-08511
Brand Name
HYGITECH
Version/Model Number
HY-08511
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
78ee11df-0060-4556-8ace-f73737665405
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
03615140005227
Quantity per Package
5
Contains DI Package
03615140005210
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 |