Pectus Tunneling Instrument, short, scaled 020-00010

GUDID 04260029580068

MedXpert GmbH

Vascular graft tunneller
Primary Device ID04260029580068
NIH Device Record Key83aff703-16bf-407c-a07a-5015ef57c6df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePectus Tunneling Instrument, short, scaled
Version Model Number020-00010
Catalog Number020-00010
Company DUNS331019344
Company NameMedXpert GmbH
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4976345085630
Emailask-the-xpert@medXpert.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104260029580068 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260029580068]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-09

Devices Manufactured by MedXpert GmbH

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04260029584714 - Pectus screwdriver2018-10-05
04260029586565 - Pectus Bar Stabilizer, Universal, R, 2 x Ø4x8 mm2018-08-10
04260029586572 - Pectus Bar Stabilizer, Universal, L, 2 x Ø4x8 mm 2018-08-10
04260029580204 - Pectus Allergy Test Plate2018-06-26
04260029580235 - Pectus Bar Template, 178 mm2018-06-26
04260029580242 - Pectus Bar Template, 203 mm2018-06-26
04260029580259 - Pectus Bar Template, 229 mm2018-06-26

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