L-Hook Blunt OS511

GUDID B3545115

L-Hook Blunt

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device IDB3545115
NIH Device Record Keyff5e3e47-29ec-4ff8-ad9a-22d5787d488b
Commercial Distribution Discontinuation2023-07-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameL-Hook Blunt
Version Model NumberOS511
Catalog NumberOS511
Company DUNS047063695
Company NameORANGE SURGICAL INSTRUMENTS, LLC
Device Count90
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
HIBCCB3545115 [Unit of Use]
HIBCCB3545OS115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


[B3545115]

Peracetic Acid


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-17
Device Publish Date2023-07-07

On-Brand Devices [L-Hook Blunt]

B354OS511L-Hook Blunt
B3545113L-Hook Blunt
B3545112L-Hook Blunt
B3545111L-Hook Blunt
B354OS5110L-Hook Blunt
B3543509Needle Holder Curved Left
B3543505Needle Holder Curved Left
B3543504Needle Holder Curved Left
B3543503Needle Holder Curved Left
B3543502Needle Holder Curved Left
B354C3501Needle Holder Curved Left
B3543499Needle Holder straight
B3543495Needle Holder straight
B3543494Needle Holder straight
B3543493Needle Holder straight
B3543492Needle Holder straight
B3543491Needle Holder straight
B354C3490Needle Holder straight
B3545119L-Hook Blunt
B3545115L-Hook Blunt
B3545114L-Hook Blunt

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