JOSEPH LAMELAS Atrial Lift System MI-ALS-001

GUDID 10858733006014

The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.

Biorep Technologies, Inc.

Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor Atrial retractor
Primary Device ID10858733006014
NIH Device Record Key4e693e2b-2be3-4edb-a895-05b8286466e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameJOSEPH LAMELAS Atrial Lift System
Version Model Number10.0
Catalog NumberMI-ALS-001
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858733006017 [Primary]
GS110858733006014 [Package]
Contains: 00858733006017
Package: Shelf Box [6 Units]
In Commercial Distribution

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


[10858733006014]

Radiation Sterilization


Device Entry Metadata

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

Devices Manufactured by Biorep Technologies, Inc.

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10858733006014 - JOSEPH LAMELAS Atrial Lift System2024-05-01The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.
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