STORM Sterile Operating Kit

GUDID 5060309870020

Sterile Storm Operating Kit

METAPHYSIS LLP

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID5060309870020
NIH Device Record Keya64a6451-66ea-46ea-a6dc-eef0c34e2887
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTORM Sterile Operating Kit
Version Model Number1-10-10
Company DUNS219570490
Company NameMETAPHYSIS LLP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS105060309870013 [Primary]
GS15060309870020 [Package]
Contains: 05060309870013
Package: Carton [5 Units]
In Commercial Distribution

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by METAPHYSIS LLP

05060309870433 - STORM2023-05-12 STORM STERILE OPERATING KIT (1-10-10 wires only) Pack of 5
05060309870297 - STORM NON STERILE operating kit2018-07-06
5060309870020 - STORM Sterile Operating Kit2018-03-29Sterile Storm Operating Kit
5060309870020 - STORM Sterile Operating Kit2018-03-29 Sterile Storm Operating Kit
05060309872000 - IOS2018-03-29 IOS external fixator system (Long)
05060309872017 - IOS2018-03-29 IOS external fixator system (short)

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