Guiding Instrument 62403

GUDID 09120034303692

Guiding Instrument, 5 Parts, Sacral Rod

I.T.S. GmbH

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Primary Device ID09120034303692
NIH Device Record Key984b75da-dafa-4afd-a6ad-cbaaa6e2e6fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuiding Instrument
Version Model Number62403
Catalog Number62403
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120034303692 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


[09120034303692]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-08
Device Publish Date2018-11-07

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