Duns Number:825673239
Device Description: AMSure® Shave Prep TrayCONTENTS:1 each Lidded Tray with Two Compartments1 each Razor1 each AMSure® Shave Prep TrayCONTENTS:1 each Lidded Tray with Two Compartments1 each Razor1 each Soap Sponge1 each Underpad1 each Absorbent Towel2 each Non-Woven Gauze2 each Cotton Tipped Applicators
Catalog Number
SPT001
Brand Name
AMSure® Shave Prep Tray
Version/Model Number
1
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)
Yes
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
28a894ba-fe2b-4690-92c8-e60c23339b0e
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
June 01, 2018
Package DI Number
40704411008089
Quantity per Package
20
Contains DI Package
10704411008088
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |