8mm Plug x 5M Monopolar Cable Reusable OS-MCR-8mm x 5MR

GUDID B354OSMCR8MMX5MR10

8mm Plug x 5M Monopolar Cable Reusable

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

Primary Device ID	B354OSMCR8MMX5MR10
NIH Device Record Key	e2397366-1540-4dcc-af5f-3fead975db48
Commercial Distribution Discontinuation	2019-11-15
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	8mm Plug x 5M Monopolar Cable Reusable
Version Model Number	OS-MCR-8mm x 5MR
Catalog Number	OS-MCR-8mm x 5MR
Company DUNS	047063695
Company Name	ORANGE SURGICAL INSTRUMENTS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B354OSMCR8MMX5MR0 [Primary]
HIBCC	B354OSMCR8MMX5MR10 [Package] Contains: B354OSMCR8MMX5MR0 Package: [10 Units] Discontinued: 2019-11-15 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101733

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

[B354OSMCR8MMX5MR10]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-11-15
Device Publish Date	2016-11-15

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