SureProbe

GUDID 00850013050055

SureProbe ENT, 80mm, Oral, Straight Dissecting Tip Assembly

Clinicon Corporation

General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use
Primary Device ID00850013050055
NIH Device Record Key2b80cbe6-7ae3-4366-8b9b-d23f43a39446
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureProbe
Version Model Number4008
Company DUNS785275777
Company NameClinicon Corporation
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013050055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-13
Device Publish Date2021-05-05

On-Brand Devices [SureProbe]

00850013050093SureProbe ENT, Oto, 70mm Single Curve Assembly
00850013050086SureProbe ENT, Larynx, 240mm Malleable Dissecting Tip Assembly
00850013050079SureProbe ENT, Pedriatric, Larynx, 140mm Malleable Dissecting Tip Assembly
00850013050062SureProbe ENT, 80mm, Oral, Single Curved Dissecting Tip Assembly
00850013050055SureProbe ENT, 80mm, Oral, Straight Dissecting Tip Assembly
00850013050048SureProbe, ENT, 50mm, Nasal, Single Curved Dissecting Tip Assembly
00850013050031SureProbe, ENT, 50mm, Nasal Straight Dissecting Tip Assembly
00850013050024SureProbe, Neuro, 80mm Straight Dissecting Tip Assembly Copy
00850013050017SureProbe, Neuro, 50mm Straight Dissecting Tip Assembly
00850013050000SureProbe, Neuro, 40mm Straight Dissecting Tip Assembly

Trademark Results [SureProbe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SUREPROBE
SUREPROBE
77956878 not registered Dead/Abandoned
Clinicon Corporation
2010-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.