Duns Number:102422578
Device Description: Single-use barrier sleeve used on the display portion of the Precise SHP Diode Laser.
Catalog Number
-
Brand Name
Precise SHP Display Barrier Sleeve
Version/Model Number
002-00243
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
K123443,K123443
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d833c29b-5a89-4f90-acb9-af2018f4aba3
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
00872320003203
Quantity per Package
250
Contains DI Package
00872320003470
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |