Reusable Monpolar Handle OS-RMH-B

GUDID B354OSRMHB10

Reusable Monpolar Handle

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device IDB354OSRMHB10
NIH Device Record Key505f7b59-9790-4acc-b150-3e6c0b9e4ede
Commercial Distribution Discontinuation2019-11-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameReusable Monpolar Handle
Version Model NumberOS-RMH-B
Catalog NumberOS-RMH-B
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB354OS175BC0 [Primary]
HIBCCB354OSRMHB0 [Primary]
HIBCCB354OSRMHB10 [Package]
Contains: B354OSRMHB0
Package: [10 Units]
Discontinued: 2019-11-14
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


[B354OSRMHB10]

Peracetic Acid


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-14
Device Publish Date2016-11-14

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