Locking/Ratcheting Handle OSC6000R

GUDID B354OSC6000R0

Locking/Ratcheting Handle

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device IDB354OSC6000R0
NIH Device Record Keyb74a813b-70b3-4606-a20c-187769200ba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocking/Ratcheting Handle
Version Model NumberOSC6000R
Catalog NumberOSC6000R
Company DUNS047063695
Company NameORANGE SURGICAL INSTRUMENTS, LLC
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 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
HIBCCB354OSC6000R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


[B354OSC6000R0]

Peracetic Acid


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-24
Device Publish Date2021-08-16

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