Pretzelflex - Surgical Retraction System

GUDID 05051986009759

3mm Sterilisation Sleeve

SURGICAL INNOVATIONS LIMITED

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Primary Device ID	05051986009759
NIH Device Record Key	c9613314-f4b8-4a44-b6df-ad57ac74966c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pretzelflex - Surgical Retraction System
Version Model Number	SHR7331
Company DUNS	771051935
Company Name	SURGICAL INNOVATIONS LIMITED
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	true
Expiration Date	false
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
GS1	05051986009759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123110

FDA Product Code

GCJ	Laparoscope, General & Plastic Surgery