Duns Number:033809722
Device Description: A non-sterile head covering designed as a cap intended to be worn by surgical staff during A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
Catalog Number
16300030
Brand Name
Forsure
Version/Model Number
16300030
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"
-
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
FYF
Product Code Name
Cap, Surgical
Public Device Record Key
33492c03-59b2-40b0-bde1-128351ed50a5
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
February 12, 2018
Package DI Number
20897633001665
Quantity per Package
5
Contains DI Package
00897633001661
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |