TEA-3X

GUDID 04058749085990

CERAMO CONCEPT X punch 40° upw. 3.0 x 200 mm

Fehling Instruments GmbH & Co. KG

Orthopaedic joint/limb rongeur
Primary Device ID04058749085990
NIH Device Record Key040f7246-7eed-4367-b808-a4ce21701bb5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTEA-3X
Catalog NumberTEA-3X
Company DUNS315028238
Company NameFehling Instruments GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Customer Support Contacts

Phone800 334-5464
Emailinfo@fehlingsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104058749085990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAERongeur, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04058749085990]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-17
Device Publish Date2017-12-18

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