Duns Number:831996595
Device Description: R-134a in a canister for use in a Candela laser system. The gas is used for reduction of p R-134a in a canister for use in a Candela laser system. The gas is used for reduction of pain by cooling of skin prior to treatment with a Candela laser system.
Catalog Number
RLMDGPD12C840
Brand Name
OriginAL Pure Cryogen
Version/Model Number
RLMDGPD12C840
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
a8d024f6-4d1f-442e-85c0-f59dfc9bfb8a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 13, 2017
Package DI Number
10819601020013
Quantity per Package
12
Contains DI Package
00819601020016
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 | 281 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |