MI Intercostal Retractor System (IRS) 222 Small Blade Set MI-IRS-SB-P01

GUDID 00858733006086

The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

Biorep Technologies, Inc.

Surgical retractor/retraction system blade, reusable
Primary Device ID00858733006086
NIH Device Record Key8b3ba76c-61d1-4713-8556-b90f1083346f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMI Intercostal Retractor System (IRS) 222 Small Blade Set
Version Model Number3.0
Catalog NumberMI-IRS-SB-P01
Company DUNS073724333
Company NameBiorep Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS100858733006086 [Primary]

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


[00858733006086]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-01
Device Publish Date2024-04-23

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