Opus Colibri 0.7mm Single-use Tip Set (X6) AACL03052004

GUDID 17290110122154

Opus Colibri 0.7mm Single-use Tip Set of 6 units

ALMA LASERS LTD.

Radio-frequency skin contouring system
Primary Device ID17290110122154
NIH Device Record Keyed89d99e-3fea-4391-ab03-2b8dd582367c
Commercial Distribution Discontinuation2021-11-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOpus Colibri 0.7mm Single-use Tip Set (X6)
Version Model Number1
Catalog NumberAACL03052004
Company DUNS532283264
Company NameALMA LASERS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290110122154 [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 Date2021-11-22
Device Publish Date2021-11-14

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