Secret PRO Articulated Arm

GUDID 08800016903706

CLASSYS Inc.

Dermatological carbon dioxide laser system
Primary Device ID08800016903706
NIH Device Record Keyd90796bf-b888-487c-b2a6-d4e84f8e8e27
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecret PRO Articulated Arm
Version Model NumberFRX-C2
Company DUNS689842183
Company NameCLASSYS Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016903706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-08
Device Publish Date2024-10-31

Devices Manufactured by CLASSYS Inc.

08800016903683 - Secret PRO Set Package2024-11-08
08800016903690 - Secret PRO Main Unit2024-11-08
08800016903706 - Secret PRO Articulated Arm2024-11-08
08800016903706 - Secret PRO Articulated Arm2024-11-08
08800016903713 - Secret PRO Scanner Handpiece2024-11-08
08800016903720 - Secret PRO Needle Hanpdiece2024-11-08
08800016903737 - Secret PRO Bigger Handpiece2024-11-08
08800016903744 - Secret PRO Smartcure Handpiece2024-11-08
08800016903195 - Fraxis Duo 25Pin Needle Tip2024-11-07

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