Dermal Cooling System M1-SC-FR1-100-1

GUDID 00850019947182

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. benign lesions of the skin.

R2 DERMATOLOGY INC.

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Primary Device ID00850019947182
NIH Device Record Keydc51776c-0e6f-47ca-aa6c-b9083974e1df
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermal Cooling System
Version Model NumberM1-SC-FR1-100-1
Catalog NumberM1-SC-FR1-100-1
Company DUNS080023734
Company NameR2 DERMATOLOGY 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com
Phone+1(925)378-4400
Emailinfo@r2technologies.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019947182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [Dermal Cooling System]

B563HP0030The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
B563HP0020The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
B563C20010The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
B563HP0050The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
B563HP0040The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
00850019947182The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
00850019947014The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
00850019947007The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur

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