Maryland 45 Degree inner shaft 43cm

GUDID B354263

Maryland 45 Degree inner shaft 43cm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Primary Device ID	B354263
NIH Device Record Key	c5ee40d1-e0e7-4d2f-865f-cf461bc59d71
Commercial Distribution Status	In Commercial Distribution
Brand Name	Maryland 45 Degree inner shaft 43cm
Version Model Number	C263B
Company DUNS	047063695
Company Name	ORANGE SURGICAL INSTRUMENTS, LLC
Device Count	99999
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	false
Serial Number	true
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	B354263 [Unit of Use]
HIBCC	B354C2631 [Primary]
HIBCC	B354C2632 [Primary]
HIBCC	B354C2633 [Primary]
HIBCC	B354C2634 [Primary]
HIBCC	B354C2635 [Primary]
HIBCC	B354C263B3 [Primary]
HIBCC	B354C263B4 [Primary]
HIBCC	B354C263B5 [Primary]
HIBCC	B354C263B9 [Primary]

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	false

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-07-24
Device Publish Date	2023-07-14

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